scholarly journals The Effect of Dual Strain Probiotic on the Growth and Feeding Intolerance in Premature Neonates of Kabul city: A Randomized Clinical Trial

Author(s):  
Mansoor Aslamzai ◽  
Abdul Rahim Raheen ◽  
Mohammad Farouq Hamidi ◽  
Zemary Hassin

Abstract Background: Prematurity is prevalent worldwide and accounts as the leading cause of neonatal death. Slow weight gain, feeding intolerance, prolong hospital stay, recurrent infection and high mortality are significant issues for preterm neonates. Dual strain probiotic can manage such complication of prematurity. Objective: To evaluate the effectiveness of dual strain probiotic on weight gaining and feeding intolerance of preterm neonates in Kabul city.Method: This randomized controlled trial conducted at Neonatal units of Malalai and Maiwand Hospitals in Kabul city. Finally, 84 preterm neonates assessed for the effect of dual strain probiotic. The clinical parameters were daily weight gain and the risk of feeding intolerance and neonatal mortality. Statically analysis was performed by SPSS 20. Results: Forty-two premature neonates in dual strain probiotic group and another forty-two preterm babies in control group were investigated. The preterm neonates in probiotic versus control group had mean age (7.2±6.3 vs 6.8±3.3 day; P=0.63), weight (1495.5±273 vs 1476.2±273 g; P=0.75) and gestational age (33.6±2.1 vs 32.9±2.4 week; p=0.14). Sex distribution in probiotic group was (boys 54.4%, girl 45.2%) and in control group was (boys 50%, girl 50%). Both groups were observed for mean days of (17.6±6.4 vs 18.8±6.3; P=0.45). The premature newborns in probiotic versus control group had mean daily weight gain (15.4±9.4 vs 10±7.9g; CI=1.75-9.31, P=0.005), risk of feeding intolerance (RR=0.65, CI=0.1-4.1, P=0.6) and risk of mortality during hospital stay (RR=0.65, CI=0.1-0.41, P=0.8).Conclusion: Preterm neonates in our country had slow growth than high-income countries. Dual strain probiotic significantly improved the daily weight gain of premature neonates. However, probiotic also decreased the risk of feeding intolerance and death during hospital stay but these findings were not statistically significant.Clinical trial registration number: This RCT was registered in the Australian New Zealand Clinical Trials Registry with the number of ACTRN12620000538943. Date of Registration is first May 2020. https://www.anzctr.org.au/ACTRN12620000538943.aspx

2017 ◽  
Vol 4 (5) ◽  
pp. 1792 ◽  
Author(s):  
Sunita Arora ◽  
Mandeep Singh Khurana ◽  
Ritish Saini

Background: Necrotizing enterocolitis is defined as an inflammatory bowel necrosis in premature infants and is major cause of morbidity and mortality in neonatal intensive care units throughout the world. We aim to study the role of probiotics in reducing incidence and severity of necrotizing enterocolitis in preterm neonates ≤34 weeks and its role on secondary outcomes like mortality, time to reach full feeds, daily weight gain, days of hospitalization and effect on nosocomial infections.Methods: This study was a prospective randomized controlled interventional trial conducted in SGRDIMSAR, Amritsar. A sample size of 150 was selected. 75 were randomized to test group and 75 to control group by simple random sampling.Results: The incidence of NEC was significantly lower in the test group compared with the control group (1 of 75 neonates vs 12 of 75 neonates; p=0.001). The severity of NEC, nosocomial sepsis and mean duration of hospital stay was significantly lower in the test group. Daily weight gain was significantly higher in the test group. There was no significant difference in mean age of onset of NEC, mortality and mean age to reach full feeds in two groups.Conclusions: Incidence and severity of NEC was less in the probiotic group. Daily weight gain was better, nosocomial sepsis and mean duration of hospital stay were less in the probiotic group. 


2020 ◽  
Author(s):  
Emily Muthoni Nyaga ◽  
Nehad Sabry Basiouny ◽  
Fabian Omoding Esamai ◽  
Gamalat El-Sayed Mansy

Abstract Background: Owing to immaturity of their body systems, preterm neonates are susceptible to feeding intolerance, slowed growth and long hospitalization periods among others. Tactile-kinesthetic stimulation, a moderate pressure of the skin and joint movement has been widely researched on among preterm neonates; the studies have predominately focused on weight gain and the potential underlying mechanism. This study focuses on effect of tactile-kinesthetic stimulation on amount of feeds, feeding intolerance and weight of moderate and late preterm neonates. Methods: A quasi-experimental study comprising 72 preterm neonates born at 28 to <37 weeks gestation age (GA) was conducted. Subjects were divided into two groups; control and tactile-kinesthetic stimulation (TKS). Neonates in the TKS group received massage for 15 minutes per session; 3 times a day for 10 days while control group had standard nursery care. Neonates’ amount of feeds and signs of feeding intolerance were assessed on days 3, 10, 17, and 23 of life while weight was measured on alternate days stating on day 3 up to day 23. Mann Whitney U test, Student t-test, Chi-square test, and Fisher’s exact test were used to determine whether there was any difference in feeding parameters and weight between TKS and control groups. Results: Although amount of feeds didn’t differ between the groups, TKS group neonates had fewer episodes of feeding intolerance compared to those in control group on the 10 th ( p = .03), 17 th ( p = .00), and 23 th ( p = .00) day of life. Moderate preterm neonates didn’t differ in weight gain however; late preterm neonates in TKS group had significantly more weight gain than the control. Conclusion: Tactile-kinesthetic stimulation reduces feeding intolerance and enhance weight gain in moderate preterm neonates. Key words: Preterm neonates, tactile-kinesthetic stimulation, feeding intolerance, and weight. Trial registration: ClinicalTrials.gov NCT04287322, registered on 27/02/2020. Retrospectively registered.


2021 ◽  
Vol 55 (9) ◽  
Author(s):  
Shary May M. Baton ◽  
Maria Esterlita T. Villanueva-Uy ◽  
Socorro De Leon-Mendoza

Background. Kangaroo Mother Care (KMC) is the standard of care for stable low birth weight infants. Provision of KMC to intubated preterm infants may also be beneficial, but strong evidence is still lacking. Objective. To determine the effectiveness of KMC in decreasing mortality among intubated preterm neonates. Study Design. This is a non-blinded, parallel, non-inferiority randomized controlled trial. Methodology. All intubated, preterm admissions, 28-36 weeks gestation, weighing 600-2000 grams, with respiratory distress were included. They were randomized to the intervention group who received KMC for 2-4 hours daily while intubated and the control group who received care inside an incubator. Participants’ physiologic status – before, during, and after the intervention – was recorded. The primary outcome was mortality. Secondary outcomes included comorbidities, days intubated, and hospital stay. Results. There was a total of 32 patients. The risk of dying in the KMC group (n=16) was significantly reduced by 78% (RR 0.22; 95% CI 0.06 - 0.87 p=0.009). The KMC patients were also less likely to have hypothermia, nosocomial pneumonia, NEC, and late-onset neonatal sepsis (p<0.05). The KMC group had higher blood sugar levels (110 vs. 58, p=0.001) and required fewer days of intubation (3.5 vs.1.5 days, p<0.000) compared to the control group. There was no difference in the duration of the hospital stay. Conclusion. KMC is effective in decreasing mortality among intubated preterm neonates. Other comorbidities and days of intubation were also reduced.


2017 ◽  
Vol 39 (2) ◽  
pp. 82-87
Author(s):  
Sadeka Choudhury Moni ◽  
MA Mannan ◽  
Sanjoy Kumer Dey ◽  
Arjun Chandra Dey ◽  
Debashish Saha ◽  
...  

Background: Establishment of full enteral feed is a major challenge in the care of preterm low birth weight (LBW) neonates. Probiotics are live microbial supplements that colonize preterm bowel with favourable flora, improve tolerance to feed and promotes growth of these premies.Objective: To determine the effect of probiotic supplementation on feed tolerance, postnatal weight gain, duration of hospital stay in preterm low birth weight babies.Methods : This prospective clinical trial was conducted in the Neonatal Intensive Care Unit (NICU), Bangabandhu Sheikh Mujib Medical University, (BSMMU) from February, 2012 to November, 2012. A total of 65 preterm, low birth weight ( LBW) newborns were included in this study. A multistrain probiotic suspension was given once daily to the infants in probiotic group along with expressed breast milk (EBM) through the nasogastric tube/ dropper from the first day of feed which was continued till attainment of full feed. Those in controls received only expressed breast milk. Weight, feed volume increment, features of intolerance were followed up daily. Relevant investigations were done whenever indicated.Results: The mean time to reach full enteral feed in probiotic and control group was 13.71±3.4 vs 16.53±6.13; p<0.05. But weight gain was not affected by supplementation. Hospital stay was shorter in supplemented group.Conclusion: Probiotic supplementation in preterm low birth weight babies improves feed tolerance and decreases hospital stay but does not affect weight gain.Bangladesh J Child Health 2015; VOL 39 (2) :82-87


Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3056
Author(s):  
Eva Karaglani ◽  
Inge Thijs-Verhoeven ◽  
Marjan Gros ◽  
Christina Chairistanidou ◽  
Giorgos Zervas ◽  
...  

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55–80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of −3 g/day [mean difference (95% CI) test vs. control: −0.474 (−2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants’ weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.


Open Medicine ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. 139-145
Author(s):  
Jelena Vucic ◽  
Miodrag Vucic ◽  
Tatjana Stankovic ◽  
Hristina Stamenkovic ◽  
Sandra Stankovic ◽  
...  

Abstract Not fully maturated immune system in preterm neonates may contribute to the increased susceptibility to infection. The levels of some cytokines can be useful in the prediction and diagnosis of sepsis in premature neonates. In the present study, we evaluated the potential predictive role of IFN-γ and IL-5 in cord and venous blood, together with the determination of C-reactive protein and procalcitonin (PCT) for sepsis development in premature neonates. A total of 80 participants were included. The laboratory results and clinical histories showed that 21 participants had sepsis. Early onset sepsis was detected in 3 patients while late onset sepsis was observed in 18 participants. The venous plasma levels of IFN-γ and PCT was markedly increased in sepsis groups when compared to the participants without sepsis. On the other hand, levels of IL-5 did not significantly change in the evaluated groups of sepsis and in the control group of participants. Simultaneously, plasma venous levels were not altered in any of the evaluated groups. Obtained findings suggest that venous plasma levels of IFN-γ, rather than levels of IFN-γ in cord blood plasma, and PCT may have predictive potential for sepsis development in preterm neonates. Further studies are necessary to get more comprehension of the complex function of cytokines for sepsis development in preterm neonates.


Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020


2021 ◽  
Author(s):  
Hung Hui Chen ◽  
Ching-Fang Lee ◽  
Jian-Pei Huang ◽  
Li-Kang Chi ◽  
Yvonne Hsiung

BACKGROUND Excessive gestational weight gain (GWG) is a public health concern since it can lead to adverse consequences and health problems for expecting mothers and their unborn infants. There is a need to evaluate the effects of a GWG management intervention to reduce the burden and risk among overweight and obese women during pregnancy. OBJECTIVE To explore the efficacy of a mobile health (mHealth) intervention to prevent excessive GWG, overweight and obese pregnant women were invited to use an app and wearable activity tracker (WAT). METHODS A randomized controlled trial with an experimental study design. Ninety-two pregnant women were recruited, and all overweight and obese participants from the two prenatal outpatient clinics in northern Taiwan had, at less than 17 weeks gestation, a prepregnancy body mass index (BMI) ≥ 25 kg/m2. These participants were randomly assigned (1:1) by a random number table; the experimental group received an mHealth-based program using the MyHealthyWeight (MHW) app and a WAT to wear during pregnancy. The control group received standard antenatal treatments without any mHealth-based elements. Two hospital follow-up visits were scheduled at 24-26 weeks in the second trimester and 34-36 weeks in the third trimester. Sociodemographic characteristics, pregnancy physical activity questionnaire (PPAQ), a self-efficacy questionnaire and body weight were measures of interest. A generalized estimating equation (GEE) was used to examine the trajectories and the intervention effect on GWG. RESULTS No difference in GWG was found between the intervention and control groups at baseline. The weight gain trajectory in the entire cohort of women with obesity exhibited a quadratic pattern; compared with the control group, a slight increase in the intervention group was found in the second trimester. Throughout the whole pregnancy, the mHealth intervention group had a significantly lower proportion of excessive GWG in total and weekly weight gain. In particular, obese women in the intervention group, compared with obese women in the control group, gained less weight (average difference of 8.76 kg) in the third trimester. The GEE model indicated that obese women who were aged 35 years, had prepregnancy exercise habits, had perceived self-efficacy of diet, and had more physical activity had lower GWG (p<.05). CONCLUSIONS The mHealth program has shown positive results in significantly managing GWG among obese and overweight women. Among obese women, the second semester trajectory of weight gain and the lower proportion of excessive GWG were more notable than those of overweight women. Although the intervention seems to be more effective among women with obesity, our results show the potential to prevent excessive GWG during pregnancy in both overweight and obese women. Guidance may be provided to health-care professionals who wish to promote healthy diet and physical activity behaviors. CLINICALTRIAL The protocol of the study was registered in ClinicalTrials. gov (NCT04553731).


2020 ◽  
Vol 7 ◽  
Author(s):  
Alexandra Schoos ◽  
Ilias Chantziaras ◽  
Jordy Vandenabeele ◽  
Evelien Biebaut ◽  
Evelyne Meyer ◽  
...  

Postpartum dysgalactia syndrome (PPDS) is a major economic problem in modern sow farms. General treatment of PPDS consists of the use of oxytocin to promote milk ejection and non-steroidal anti-inflammatory drugs (NSAIDs) to alleviate inflammatory processes. So far, studies investigated the use of a single administration of NSAIDs after parturition in healthy and non-healthy sows. The current study investigated whether administration of meloxicam or paracetamol in sows prior to parturition improves sow and piglet health as well as performance in a farm with PPDS problems in sows. Sixty sows and 978 piglets from a Belgian farrow-to-finish farm were enrolled. Sows were randomly divided into three groups: a non-treated control group, a meloxicam-treated group and a paracetamol-treated group. Treatment was administered orally for 7 days from gestation day 113 onwards. Performance and health parameters investigated in sows were gestation length, farrowing duration, litter characteristics, colostrum yield and quality (Immunoglobulin G), litter weight gain, weaning-to-estrus interval, pregnancy rate, rectal temperature, acute phase proteins and inflammatory markers serum amyloid A, haptoglobin, interferon γ, interleukin 1β and 6 backfat, constipation and feed refusal. Performance and health parameters in piglets were birthweight, average daily weight gain, colostrum intake and mortality. Paracetamol-treated sows showed a significantly (P = 0.04) lower rectal temperature (mean ± SD: 38.09 ± 0.18°C) than the meloxicam-treated sows (38.24 ± 0.18°C), but not than the control group (38.22 ± 0.18°C). Sows of the paracetamol-treated group had a significantly (P = 0.001) longer gestation length (116.3 ± 0.9 days) than sows of the control group (115.3 ± 0.6 days), but not than meloxicam-treated sows (115.9 ± 0.9 days). No significant differences between the three groups were found for all the other parameters. In conclusion, the prophylactic oral administration of either meloxicam or paracetamol for 7 days starting 2 days prior to farrowing did not show beneficial effects on both health and performance parameters of sows and piglets.


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