scholarly journals Dietary Blueberry and Soluble Fiber Improve Serum Antioxidant and Adipokine Biomarkers and Lipid Peroxidation in Pregnant Women with Obesity and at Risk for Gestational Diabetes

Antioxidants ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1318
Author(s):  
Arpita Basu ◽  
Jeannette Crew ◽  
Jeffrey L. Ebersole ◽  
Jefferson W. Kinney ◽  
Arnold M. Salazar ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
High Risk ◽  
Pregnant Women ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Soluble Fiber ◽  
Plasminogen Activator Inhibitor 1 ◽  
Serum Samples ◽  
Metabolic Complications

Pregnancies affected by obesity are at high risk for developing metabolic complications with oxidative stress and adipocyte dysfunction contributing to the underlying pathologies. Few studies have examined the role of dietary interventions, especially those involving antioxidants including polyphenolic flavonoids found in fruits and vegetables on these pathologies in high-risk pregnant women. We conducted an 18 gestation-week randomized controlled trial to examine the effects of a dietary intervention comprising of whole blueberries and soluble fiber vs. control (standard prenatal care) on biomarkers of oxidative stress/antioxidant status and adipocyte and hormonal functions in pregnant women with obesity (n = 34). Serum samples were collected at baseline (<20 gestation weeks) and at the end of the study period (32–26 gestation weeks). Study findings showed maternal serum glutathione and antioxidant capacity to be significantly increased, and malondialdehyde to be decreased in the dietary intervention vs. control group (all p < 0.05). Among the adipokine biomarkers, serum plasminogen activator inhibitor-1 and visfatin, as biomarkers of adipocyte dysfunction and insulin resistance, were also decreased following dietary intervention (all p < 0.05). These findings support the need for supplementing maternal diets with berries and fiber to improve oxidative stress and risks of metabolic complications during pregnancy.

INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Pravastatin to Prevent Preeclampsia and its Effects on sFlt1/PLGF Levels

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Neonatal Morbidity ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Plgf Ratio

Objectives To evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio. Study Design This is an open labelled RCT part of INOVASIA trial. Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin and before delivery. The main outcome was the rate of maternal preeclampsia, maternal-perinatal outcomes, and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly (p=0.048) lower in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights (2931 + 537 vs 2625 + 872 g; p=0.006), lower Apgar scores < 7 (2.5 vs 27.5%, p=0.002), composite neonatal morbidity (0 vs 20%, p=0.005) and NICU admission rates (0 vs 15%, p=0.026). All biomarkers show a significant deterioration in the control group compared with non significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the angiogenic imbalance.

Targeting the perinatal diet to modulate the gut microbiota increases dietary variety and prebiotic and probiotic food intakes: results from a randomised controlled trial

2020 ◽  
pp. 1-13
Author(s):  
Samantha L Dawson ◽  
Mohammadreza Mohebbi ◽  
Jeffrey M Craig ◽  
Phillip Dawson ◽  
Gerard Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Gut Microbiota ◽  
Pregnant Women ◽  
Diet Quality ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Dietary Variety ◽  
Probiotic Food ◽  
Randomised Controlled

Abstract Objective: To evaluate the hypothesis that a perinatal educational dietary intervention focused on ‘eating for the gut microbiota’ improves diet quality of pregnant women pre- and postnatally. Design: The Healthy Parents, Healthy Kids study is a prospectively registered randomised controlled trial designed to evaluate the efficacy of a dietary intervention in altering the maternal and infant gut microbiota and improving perinatal diet quality. Eligible pregnant women were randomised to receive dietary advice from their healthcare provider or to additionally receive a three session dietary intervention. Dietary data were collected at gestation weeks 26, 31, 36 and postnatal week 4. Outcome measures were diet quality, dietary variety, prebiotic and probiotic food intakes, energy, fibre, saturated fat and discretionary food intakes. Between-group differential changes from baseline before and after birth in these dietary measures were assessed using generalised estimating equations. Setting: Melbourne, Australia. Participants: Healthy pregnant women from gestation week 26. Results: Forty-five women were randomised (twenty-two control, twenty-three intervention). Compared with the control group, the intervention group improved diet quality prior to birth (5·66 (95 % CI 1·65, 9·67), Cohen’s d: 0·82 (se 0·33)). The intervention improved dietary variety (1·05 (95 % CI 0·17, 1·94), d: 0·66 (se 0·32)) and increased intakes of prebiotic (0·8 (95 % CI 0·27, 1·33), d: 0·91 (se 0·33)) and probiotic foods (1·05 (95 % CI 0·57, 1·53), d: 1·3(se 0·35)) over the whole study period compared with the control group. Conclusion: A dietary intervention focused on ‘eating for the gut microbiota’ can improve aspects of perinatal diet quality during and after pregnancy.

scholarly journals INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Prophylactic Pravastatin in the Prevention of Preeclampsia and its Effects on sFlt1/PLGF Levels in Pregnant Women at High Risk of Developing Preeclampsia

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Secondary Outcomes ◽  
Plgf Ratio

Objectives The study aim is to evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio in the Surabaya cohort of the INOVASIA trial. Setting This study involved 2 academic hospital (a tertiary and secondary center) in Surabaya, Indonesia. Participants Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. Inteventions The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin, and just before delivery. Primary and Secondary Outcomes The primary outcome was the rate of maternal preeclampsia, secondary outcomes included maternal-perinatal outcomes and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly lower (p 0.048) in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights, higher Apgar scores, and lower composite neonatal morbidity and NICU admission rates. All biomarkers show a significant deterioration in the control group compared with non-significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the anti-angiogenic/pro-angiogenic imbalance. Trial Registration Clinical Trial Gov (ID: NCT03648970)

The Effect of Dalteparin on Coagulation Activation during Pregnancy in Women with Thrombophilia: A Randomised Trial.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 874-874
Author(s):  
Karim Abou-Nassar ◽  
Marc Rodger ◽  
Michael J. Kovacs ◽  
Steve Doucette ◽  
Ramsay Tim ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Study Drug ◽  
Control Group ◽  
Coagulation Activation ◽  
Time Points ◽  
Box Plots ◽  
D Dimer

Abstract Background: Low-molecular weight heparin (LMWH) is increasingly being used for prophylaxis of venous thromboembolism (VTE) and prevention of pregnancy associated morbidity in pregnant women with thrombophilia. Objective: We sought to determine if the administration of prophylactic doses of LMWH down regulates coagulation activation in high risk pregnant women with thrombophilia. Methods: This sub-study was planned as part of a randomized open label controlled trial (Thrombophilia in Pregnancy Prophylaxis Study (TIPPS)) in which patients at high risk of pregnancy complications with confirmed thrombophilia are randomized to receive either dalteparin (5000 units/day until 20 weeks then 5000U q12h until 37 weeks or onset of labor) or no treatment. Blood samples were collected at baseline, day 7–9 (after starting study drug), week 20 (before increasing study drug), week 36 (prior to stopping study drug) and at the time of admission to the labor and delivery unit. Samples were not drawn at fixed times in relation to drug injection. These samples were analyzed for levels of thrombin-antithrombin complexes (TAT), prothrombin fragments 1+2 (F1+2), D-dimer and anti-Xa activity. Generalized linear mixed models were used for statistical analysis and model results were controlled for age, smoking status, type of thrombophilia and predisposing risk factors. The effect of dalteparin on TAT levels was defined as the primary outcome. Results: Of one hundred ninety eight patients eligible, 114 were enrolled in TIPPS. Seventy four were eligible for the TIPPS coagulation activation sub-study and randomized. Twenty-three patients were analyzed in the treatment group (dalteparin) and 28 patients in the control group (no intervention). Levels of coagulation activation factors F1+2, TAT and D-dimer increased significantly throughout pregnancy in both groups (p&lt;0.0001). Dalteparin prophylaxis resulted in a significant increase in anti-Xa activity through pregnancy (p&lt;0.0001) compared to controls. Dalteparin had no significant effects on the levels of TAT, F1+2 and D-dimer throughout pregnancy in thrombophilic women (figure 1). A post hoc Monte Carlo power analysis revealed that our study had over 99% and 64% power to detect reductions in TAT values on treatment of respectively 50% and 25%. Conclusion: Prophylaxis with dalteparin at doses used in this study did not reduce coagulation activation in high risk thrombophilic women during pregnancy. Figure 1 Box plots of TAT levels in high risk pregnant thrombophilic women with (closed boxes) and without (open boxes) dalteparin thromboprophylaxis at different time points during pregnancy. Day 7 represents the time after radomization in TIPPS whereas at other time points represent sepcific gestational ages. The bottom of the boxes mark the 25th percentile, the median lines mark the 50th percentile, the top of the boxes mark the 75th percentile, the bottom and top of the vertical lines mark the 5th and 95th percentile, respectively. Figure 1. Box plots of TAT levels in high risk pregnant thrombophilic women with (closed boxes) and without (open boxes) dalteparin thromboprophylaxis at different time points during pregnancy. Day 7 represents the time after radomization in TIPPS whereas at other time points represent sepcific gestational ages. The bottom of the boxes mark the 25th percentile, the median lines mark the 50th percentile, the top of the boxes mark the 75th percentile, the bottom and top of the vertical lines mark the 5th and 95th percentile, respectively.

scholarly journals Effects of a Rice Bran Dietary Intervention on the Composition of the Intestinal Microbiota of Adults with a High Risk of Colorectal Cancer: A Pilot Randomised-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 526
Author(s):  
Winnie K. W. So ◽  
Judy Y. W. Chan ◽  
Bernard M. H. Law ◽  
Kai Chow Choi ◽  
Jessica Y. L. Ching ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Intestinal Microbiota ◽  
Rice Bran ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Intestinal Health ◽  
Health Promoting

Rice bran exhibits chemopreventive properties that may help to prevent colorectal cancer (CRC), and a short-term rice bran dietary intervention may promote intestinal health via modification of the intestinal microbiota. We conducted a pilot, double-blind, randomised placebo-controlled trial to assess the feasibility of implementing a long-term (24-week) rice bran dietary intervention in Chinese subjects with a high risk of CRC, and to examine its effects on the composition of their intestinal microbiota. Forty subjects were randomised into the intervention group (n = 19) or the control group (n = 20). The intervention participants consumed 30 g of rice bran over 24-h intervals for 24 weeks, whilst the control participants consumed 30 g of rice powder on the same schedule. High rates of retention (97.5%) and compliance (≥91.3%) were observed. No adverse effects were reported. The intervention significantly enhanced the intestinal abundance of Firmicutes and Lactobacillus, and tended to increase the Firmicutes/Bacteroidetes ratio and the intestinal abundance of Prevotella_9 and the health-promoting Lactobacillales and Bifidobacteria, but had no effect on bacterial diversity. Overall, a 24-week rice bran dietary intervention was feasible, and may increase intestinal health by inducing health-promoting modification of the intestinal microbiota. Further larger-scale studies involving a longer intervention duration and multiple follow-up outcome assessments are recommended.

The effect of dalteparin on coagulation activation during pregnancy in women with thrombophilia

2007 ◽  
Vol 98 (07) ◽  
pp. 163-171 ◽  
Author(s):  
Karim Abou-Nassar ◽  
Michael Kovacs ◽  
Susan Kahn ◽  
Philip Wells ◽  
Steve Doucette ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Smoking Status ◽  
Controlled Trial ◽  
Study Drug ◽  
Control Group ◽  
Coagulation Activation ◽  
Open Label ◽  
Time Of Admission ◽  
D Dimer

SummaryLow-molecular-weight heparin (LMWH) is increasingly being used for prophylaxis of venous thromboembolism (VTE) and prevention of pregnancy associated morbidity in pregnant women with thrombophilia. We sought to determine if the administration of prophylactic doses of LMWH downregulates coagulation activation in high risk pregnant women with thrombophilia. This sub-study was planned as part of a randomized open label controlled trial (Thrombophilia in Pregnancy Prophylaxis Study[TIPPS])in which patients at high risk of pregnancy complications with confirmed thrombophilia are randomized to receive either dalteparin (5,000 units/day until 20 weeks then 5,000 units q12h until 37 weeks or onset of labor) or no treatment. Blood samples were collected at baseline, day 7–9 (after starting study drug), week 20 (before increasing study drug), week 36 (prior to stopping study drug) and at the time of admission to the labor and delivery unit. Samples were not drawn at fixed times in relation to drug injection. These samples were analyzed for levels of thrombin-antithrombin complexes (TAT), prothrombin fragments 1+2 (F1.2), D-dimer and anti-Xa activity. Generalized linear mixed models were used for statistical analysis and model results were controlled for age, smoking status, type of thrombophilia and predisposing risk factors. The effect of dalteparin onTAT levels was defined as the primary outcome. Of 198 patients eligible, 114 were enrolled in TIPPS. Ninety-one were eligible for the TIPPS coagulation activation sub-study and randomized. Thirty-nine patients were analyzed in the treatment group (dalteparin) and 46 patients in the control group (no intervention). Levels of coagulation activation factors F1.2, TAT and D-dimer increased significantly throughout pregnancy in both groups (p<0.0001). Dalteparin prophylaxis resulted in a significant increase in anti-Xa activity through pregnancy (p<0.0001) compared to controls. Dalteparin had no significant effects on the levels of TAT, F1.2 and D-dimer throughout pregnancy in thrombophilic women.A post-hoc Monte Carlo power analysis revealed that our study had 100% and 88% power to detect reductions in TAT values on treatment of 50% and 25%, respectively. Prophylaxis with dalteparin at doses used in this study did not reduce coagulation activation in high risk thrombophilic women during pregnancy.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

scholarly journals The consumption of low-calorie sweetener containing foods during pregnancy: results from the ROLO study

2021 ◽  
Author(s):  
Marie C. Conway ◽  
Shona Cawley ◽  
Aisling A. Geraghty ◽  
Niamh M. Walsh ◽  
Eileen C. O’Brien ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Dietary Intervention ◽  
Intervention Group ◽  
Glycaemic Index ◽  
Dietary Advice ◽  
Control Group ◽  
Food Groups ◽  
Food Diary ◽  
Low Calorie ◽  
Child Health Outcomes

Abstract Background/objectives Women with gestational diabetes (GDM) are advised to adapt a low glycaemic index (GI) diet, which may impact consumption of low-calorie sweeteners (LCS). LCS are increasingly popular as they add sweetness without contributing calories. This study aims to investigate the reported intakes of LCS-containing foods in women during pregnancy. Subjects/methods Pregnant women recruited for the ROLO study were included in this analysis (n = 571). Women were randomised to receive either an intervention of low-GI dietary advice or usual antenatal care. Women completed a 3-day food diary in each trimester. Nine LCS-containing food groups were identified, and the quantity (g/day) consumed was calculated. Results One-third of all pregnant women consumed LCS across each trimester of pregnancy. Of those in the intervention group who were LCS consumers in trimester 1, 71.6% were consumers in trimester 2, and 54.1% remained consumers in trimester 3. In the control group, less women remained consumers in trimester 2 and 3 at 58.1% and 41.9%, respectively. In trimester 2, following the dietary intervention, the proportion of LCS consumers in the intervention group was significantly higher than the proportion of consumers who were in the control group (p < 0.001). The most commonly consumed food groups were low-calorie fruit drinks, diet-cola drinks, and low-calorie yoghurts. Conclusions One-third of pregnant women consumed LCS. The proportion of LCS consumers increased in the intervention group compared to the control group. Further research is needed to determine exposure levels to individual LCS, and the effect of prenatal exposure to LCS on maternal and child health outcomes.

Peripheral levels of superoxide dismutase and glutathione peroxidase in youths in ultra-high risk for psychosis: a pilot study

CNS Spectrums ◽  
2017 ◽  
Vol 24 (03) ◽  
pp. 333-337 ◽  
Author(s):  
Maiara Zeni-Graiff ◽  
Adiel C. Rios ◽  
Pawan K. Maurya ◽  
Lucas B. Rizzo ◽  
Sumit Sethi ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
At Risk ◽  
Superoxide Dismutase ◽  
High Risk ◽  
Glutathione Peroxidase ◽  
Healthy Control Group ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Ultra High Risk ◽  
Healthy Control

IntroductionOxidative stress has been documented in chronic schizophrenia and in the first episode of psychosis, but there are very little data on oxidative stress prior to the disease onset.ObjectiveThis work aimed to compare serum levels of superoxide dismutase (SOD) and glutathione peroxidase (GPx) in young individuals at ultra-high risk (UHR) of developing psychosis with a comparison healthy control group (HC).MethodsThirteen UHR subjects and 29 age- and sex-matched healthy controls (HC) were enrolled in this study. Clinical assessment included the Comprehensive Assessment of At-Risk Mental States (CAARMS), the Semi-Structured Clinical Interview for DSM-IV Axis-I (SCID-I) or the Kiddie-SADS-Present and Lifetime Version (K-SADS-PL), and the Global Assessment of Functioning (GAF) scale. Activities of SOD and GPx were measured in serum by the spectrophotometric method using enzyme-linked immunosorbent assay kits.ResultsAfter adjusting for age and years of education, there was a significant lower activity of SOD and lower GPX activity in the UHR group compared to the healthy control group (rate ratio [RR]=0.330, 95% CI 0.187; 0.584, p&lt;0.001 and RR=0.509, 95% CI 0.323; 0.803, p=0.004, respectively). There were also positive correlations between GAF functioning scores and GPx and SOD activities.ConclusionOur results suggest that oxidative imbalances could be present prior to the onset of full-blown psychosis, including in at-risk stages. Future studies should replicate and expand these results.

Early Physical Therapy Effects on the High-Risk Infant: A Randomized Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 78 (2) ◽  
pp. 216-224
Author(s):  
Martha C. Piper ◽  
V. Ildiko Kunos ◽  
Diana M. Willis ◽  
Barbara L. Mazer ◽  
Maria Ramsay ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
High Risk ◽  
Motor Development ◽  
Controlled Trial ◽  
Physical Growth ◽  
Control Group ◽  
Randomized Controlled ◽  
Early Physical Therapy ◽  
The Impact

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

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