scholarly journals Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030167
Author(s):  
Justyna Romańska ◽  
Wojciech Margas ◽  
Renata Bokiniec ◽  
Paweł Krajewski ◽  
Joanna Seliga-Siwecka
Keyword(s):  
Preterm Infants ◽  
Premature Infants ◽  
Low Birthweight ◽  
Intervention Group ◽  
Central Line ◽  
Optimal Time ◽  
Control Group ◽  
Very Low Birthweight ◽  
Central Lines ◽  
The Mean

IntroductionUncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants.Methods and analysisVery low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks’ postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of −210 g.Ethics and disseminationThe Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences.Trial registration numberNCT03730883.Protocol versionVersion 3. 14.08.2019.

scholarly journals Nutritional supplementation and growth after hospital discharge in very low birthweight newborns: Randomized controlled trial / Suplementação nutricional e crescimento de recém-nascidos de muito baixo peso após alta hospitalar: Ensaio clínico randomizado

2021 ◽  
Vol 7 (10) ◽  
pp. 101149-101162
Author(s):  
Fernando Lamy Filho ◽  
Eremita Val Rafael ◽  
Roxana Desterro E Silva Da Cunha ◽  
Alcione Miranda Dos Santos ◽  
Zeni Carvalho Lamy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Preterm Infants ◽  
Gestational Age ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Intervention Group ◽  
Very Low Birthweight ◽  
Randomized Controlled

Background Evidence is insufficient to show whether fortification has any effect on growth in preterm infants after discharge. Objective to verify whether VLBW preterm infants who are supplemented with multicomponent present greater anthropometric measurements than those not supplemented. Study Design Parallel randomized controlled trial. A computer-generated random number table was used to allocate the participants. Participants Preterm infants discharged from the NICU of a University Hospital from northeast, Brazil, weighing less than 1,500 g exclusively breastfed at discharge and followed up until they reached 6 months corrected gestational age.  Intervention intervention group received Nestlé® PreNan® formula, fractionated in 2 g of powder, mixed with the mother's milk twice a day. Control group was exclusively breastfed. Follow-up was conducted until the infants reached 6 months corrected gestational age (CGA). Outcomes Growth of the anthropometrics parameters weight, head circumference (HC) and lenth with 6 months of corrected age.  Mixed effects model for longitudinal data was used. Interaction according to sex was detected and ajusted. Results Weight gain was significantly higher in the intervention group. This effect was verified only for males (p = 0.001). No statistically significant association was observed between the intervention and the head circumference or length (p = 0.211; 0.597). The weaning rate at the end of follow-up was similar in both groups. Conclusions Breastmilk supplementation may improve the weight gain of very low birthweight preterm infants up to six months corrected gestational age. This effect differed by sex and was considered significant only for males.

scholarly journals A Multifaceted Approach to Supporting Mothers of Premature Infants

2021 ◽  
Author(s):  
Parisa Mohagheghi ◽  
Afsaneh Keramat ◽  
Reza Chaman ◽  
Ahmad Khosravi ◽  
Seyed Abbas Mousavi ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Premature Infants ◽  
Premature Birth ◽  
Intervention Group ◽  
Information Support ◽  
Perceived Support ◽  
Control Group ◽  
Informational Support ◽  
Support Tool ◽  
Supportive Program

Abstract Background Premature birth exposes mothers to a strange experience for which they are not mentally ready. Premature birth exposes mothers to a strange experience for which they are not mentally ready. This study aimed to examine the effect of a multi-faceted supportive approach on the levels of perceived support in mothers. Methods The present experimental study was conducted on 143 mothers with preterm infants, (In the intervention group, 75 infants and mothers and 68 infants and mothers in the control group), in the NICUs of two educational and referral hospitals of Tehran, Iran; from Feb 14, 2016 to May 14, 2016. The inclusion criteria were: having a preterm infant with gestational age < 37 weeks, birth weight < 2500 gr, high probability of survival, Iranian nationality and ability to communicate verbally. Exclusion criteria were: preterm infants without abnormality or disabling conditions such as intra ventricular hemorrhage (IVH) grade 3 or 4. The designed intervention was conducted based on the support system pattern of mothers with premature infants. Different interventions in support (appraisal, instrumental, emotional, and informational support) of mothers in NICU were planned for the supportive program, which was gradually implemented within 3 months of the intervention. The Nurse Parent Support Tool (NPST) was used to assess the mothers' perceptions of the perceived support. The control group received routine care. The obtained data were analyzed by STATA software 13. Classified variables were analyzed using t-test, chi-square and Inverse Probability Treatment Weights (IPTW). Results After adjusted mean differences (95% confidence interval) of outcomes between two groups, results showed that the all support scores including total support, -1.83 (95% CI -1.6 to -2.06), Instrumental support, -1.23 (95% CI -1.04 to -1.43), Emotional support, -1.87 (95% CI -2.15 to 1.6) and Appraisal support, -2.01 (95% CI -1.73 to -2.29), and Informational support, -2.12 (95% CI -1.82 to -2.43), in the experimental group were significantly higher than in the control group (P<0.001). Conclusions The information, support and early intervention play important roles in the maternal empowerment to cope with her situation.

scholarly journals Reducing late-onset neonatal sepsis in very low birthweight neonates with central lines in a low-and-middle-income country setting

2021 ◽  
Vol 10 (Suppl 1) ◽  
pp. e001353 ◽  
Author(s):  
Vinay Batthula ◽  
Sanjana H Somnath ◽  
Vikram Datta
Keyword(s):  
Neonatal Sepsis ◽  
Low Birthweight ◽  
Late Onset ◽  
Central Line ◽  
Middle Income Country ◽  
Very Low Birthweight ◽  
Middle Income ◽  
Care Bundles ◽  
Central Lines ◽  
Bundle Compliance

BackgroundLate-onset neonatal sepsis (LONS) is a significant contributor to morbidity and mortality in very low birthweight (VLBW) neonates with indwelling central lines. Compliance to central line care bundles is suboptimal in low-and-middle-income country settings. Point of care quality improvement (POCQI) method may be used to improve the compliance gap. We used the POCQI method to achieve an improvement in compliance to central line care bundles with an aim to reduce LONS in a subset of VLBW neonates.MethodsA pre and post-intervention study consisting of three phases was conducted in a tertiary care neonatal intensive care unit. A root-cause analysis was undertaken to find the causes of LONS in VLBW babies with central lines. Multiple change ideas were identified and tested using sequential Plan-Do-Study-Act (PDSA) cycles to address the issue of reduced compliance to the central line care bundles. The change ideas tested in PDSA cycles which were successful were adopted. Compliance to the insertion and maintenance bundles was measured as process indicators. LONS, central line associated bloodstream infections and all-cause mortality rates were measured as outcome indicators.ResultsA total of 10 PDSA cycles testing multiple change ideas (staff education, audio-visual aids, supply issues) were undertaken during the study duration. Bundles were not being used in the study setting prior to the initiation of the study. Insertion bundle compliance was above 90% and maintenance bundle compliance increased from 23.3% to 42.2% during the intervention and sustenance phases, respectively. A 43.3% statistically significant reduction in LONS rates was achieved at the end of the study. No effect on mortality was seen.ConclusionPOCQI method can be used to improve compliance to central line care bundles which can lead to a reduction of LONS in VLBW neonates with central lines in situ.

scholarly journals Effect of Probiotics on Full Intestinal Feeding in Premature Infants: A Double Blind, Clinical Trial

2020 ◽  
Vol 30 (3) ◽  
Author(s):  
Seyedeh Zohreh Jalali ◽  
Mohammad Reza shiri ◽  
Morvarid Ghassab Shirazi
Keyword(s):  
Clinical Trial ◽  
Preterm Infants ◽  
Premature Infants ◽  
Statistical Tests ◽  
Mode Of Delivery ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Adverse Health Outcomes ◽  
Saline Administration

Background: Premature infants suffer from many problems due to the lack of evolution of the digestive system, and early onset of intestinal feeding prevents these complications. Probiotics have been used to prevent intestinal disorders in preterm infants due to their many benefits. Objectives: This study was conducted to measure the efficacy of probiotics on time to reach full intestinal feeds (120 cc/kg/day) in premature newborns. Methods: This study was double-blind randomized clinical trial. Preterm infants born at < 36 weeks and birth weight of 1000 – 2500 gr (n = 58) in 17th Shahrivar Hospital, Rasht, Iran, were randomly assigned into intervention group (oral administration of probiotics) and control group (with normal saline administration). Data were collected using a data form that includes demographic characteristics, time to full intestinal feeding, and the incidence of complications. Data were analyzed by SPSS version 21 using descriptive and analytical statistical tests. Results: The results of the study showed that the mean and standard deviation time to full intestinal feeding in the probiotic group was 5.7 ± 1.06 days, while in the placebo group was 6.72 ± 1.98 days, which was statistically significant (P = 0.002). There were no significant correlation between study variables and time to full intestinal feeding except mode of delivery (P = 0.029). Conclusions: Feeding with probiotics is recognized as an effective way to prevent adverse health outcomes in preterm infants. The present study showed that administration of probiotics reduced the time to full feeding. Therefore, it is an effective and inexpensive method to prevent intestinal disorders in newborns.

scholarly journals OP0159 EFFICACY OF COMPREHENSIVE TECHNOLOGY-ASSISTED HOME-BASED EXERCISE IN ANKYLOSING SPONDYLITIS: A RANDOMIZED, CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 100.3-100
Author(s):  
Y. Wang ◽  
X. Liu ◽  
Y. Shi ◽  
X. Ji ◽  
W. Wang ◽  
...  
Keyword(s):  
Exercise Intervention ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Group Differences ◽  
Control Group ◽  
Home Based ◽  
The Mean

Background:Clinical practice guidelines recommend that exercise is an essential component in the self-management of Ankylosing Spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be burdensome and patients may decline participation, whereas, effective home-based exercise interventions that do not need regular medical center visits are likely to be more accessible and acceptable for patients with AS. Recently, increasing evidences have been accumulated that the wearable devices could facilitate patients with inflammatory arthritis by giving exercise instructions and improving self-efficacy. Therefore, patients with AS may benefit from an effective technology-assisted home-based exercise intervention.Objectives:To investigate the efficacy of a comprehensive technology-assisted home-based exercise intervention on disease activity in patients with AS.Methods:This study was a 16-week assessor-blinded, randomized, waiting-list controlled trial (ChiCTR1900024244). Patients with AS were randomly allocated to the home-based exercise intervention group and the waiting-list control group. A 16-week comprehensive exercise program consisting of a moderate intensity (64%-76% HRmax) aerobic training for 30min on 5 days/week and a functional training for 60min on 3 days/week was given to patients in the intervention group immediately after randomization, with 1.5h training sessions for two consecutive days by a study physical therapist at baseline and Week 8. The aerobic exercise intensity was controlled by a Mio FUSE Wristband with a smartphone application. The functional training consisted of the posture training, range of motion exercises, strength training, stability training and stretching exercises. Patients in control group received standard care during the 16-week follow-up and started to receive the exercise program at Week 16. The primary outcome was ASDAS at Week 16. The secondary outcomes were BASDAI, BASFI, BASMI, ASAS HI, peak oxygen uptake, body composition and muscle endurance tests. The mean difference between groups in change from baseline was analyzed with the analysis of covariance.Results:A total of 54 patients with AS were enrolled (26 in intervention group and 28 in control group) and 46 (85.2%) patients completed the 16-week follow-up. The mean difference of ASDAS between groups in change from baseline to 16-week follow-up was −0.2 (95% CI, −0.4 to 0.003, P = 0.032), and the mean change from baseline was -0.4 (95% CI, -0.5 to -0.2) in the intervention group vs -0.1 (95% CI, -0.3 to 0.01) in the control group, respectively. Significant between-group differences were found between groups for BASDAI (−0.5 [95% CI, −0.9 to −0.2], P = 0.004), BASMI (−0.7 [95% CI, −1.1 to −0.4], P <0.001), BASFI (−0.3 [95% CI, −0.6 to 0.01], P=0.035), peak oxygen uptake (2.7 [95% CI, 0.02 to 5.3] ml/kg/min, P=0.048) and extensor endurance test (17.8 [95% CI, 0.5 to 35.2]s, P=0.044) at Week 16. Between-group differences were detected in ASAS HI (−0.9 [95% CI, −1.7 to −0.1], P=0.030), body fat percentage (−1.0 [95% CI, −2.0 to −0.01] %, P=0.048) and visceral adipose tissue (−4.9 [95% CI, −8.5 to −1.4] cm2, P=0.008) at Week 8, but not at Week 16. No significant between-group differences were detected in the total lean mass, time up and go test and the flexor endurance test during the follow-up.Conclusion:Comprehensive technology-assisted home-based exercise has been shown to have beneficial effects on disease activity, physical function, spinal mobility, aerobic capacity, and body composition as well as in improving fatigue and morning stiffness of patients with AS.References:[1]van der Heijde D, Ramiro S, Landewé R, et al. Ann Rheum Dis 2017;76:978–991.Disclosure of Interests:None declared

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

ELFIN, the United Kingdom preterm lactoferrin trial: interpretation and future questions

2020 ◽  
Author(s):  
Janet Elizabeth Berrington ◽  
William McGuire ◽  
NIcholas David Embleton
Keyword(s):  
United Kingdom ◽  
Preterm Infants ◽  
Late Onset ◽  
Disease Onset ◽  
Intervention Group ◽  
Control Group ◽  
Bovine Lactoferrin ◽  
The United Kingdom ◽  
Late Onset Sepsis ◽  
The Uk

Previous studies suggested that supplemental bovine lactoferrin (BLF) given to preterm infants (<32 weeks gestation) may reduce late onset sepsis (LOS) and necrotising enterocolitis (NEC), but have been underpowered. The Enteral Lactoferrin in Neonates (ELFIN) study, performed in the United Kingdom (UK), aimed to further address this issue with a well powered double blinded placebo controlled trial of >2200 preterm infants. ELFIN did not demonstrate a reduction in LOS or NEC, or several other clinically important measures. 316 (29%) of 1093 infants in the intervention group developed late-onset sepsis versus 334 (31%) of 1089 in the control group with an adjusted risk ratio of 0·95 (95% CI 0·86–1·04; p=0· 233). Reasons for the differences in ELFIN trial results and other studies may include population differences, the routine use of antifungals in the UK, timing of administration of the lactoferrin in relation to disease onset, or specific properties of the lactoferrin used in different trials. Further exploration is being undertaken in the UK NIHR funded Mechanisms Affecting the Guts of Preterm Infants in Enteral feeding trials (MAGPIE) study, for which results should be available soon.

Effects of an Off-Site Walking Program on Energy Expenditure, Serum Lipids, and Glucose Metabolism in Middle-Aged Women

2003 ◽  
Vol 4 (3) ◽  
pp. 181-192 ◽  
Author(s):  
Fumiko Furukawa ◽  
Keiko Kazuma ◽  
Masako Kawa ◽  
Mitsunori Miyashita ◽  
Kyohko Niiro ◽  
...  
Keyword(s):  
Energy Expenditure ◽  
Nurse Managers ◽  
Intervention Group ◽  
Density Lipoprotein ◽  
Control Group ◽  
Middle Aged ◽  
Walking Program ◽  
Before And After ◽  
The Mean ◽  
Blood Profiles

The present study aims to identify the effects of systematic walking on exercise energy expenditure (EEE) and blood profiles in middle-aged women. Fifty-two female nurse managers, aged 32 to 57 years (42.0 ± 6.2), were randomly assigned to an intervention group (IG) and a control group (CG) for a 12-week study of the walking program. EEE was measured using a microelectronic device. Blood profiles were assessed before and after the walking program. The mean EEE (kcal/kg/d) in the IG and CG was 4.73 ± 1.02 and 3.88 ± 0.81 ( P = 0.01), indicating an increase of 1.17 ± 0.98 and 0.46 ± 0.68 from baseline ( P = 0.01), respectively. The mean change in high-density lipoprotein cholesterol in the IG and CG was 1.8 ± 8.3 mg/dL and −2.9 ± 7.0 mg/dL ( P = 0.051); that in insulin was −4.5 ± 7.5 μU/dL and −0.6 ± 4.3 μU/dL ( P = 0.046), respectively. These results show that systematic walking increases EEE and improves blood profiles.

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