Clinical Trials Logo
  1. Home
  2. Low Birth Weight
  3. NCT01164124

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants — PAS  

Low Birth Weight Clinical Trial

Official title:
Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Clinical Trial Summary

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

Clinical Trial Description

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain. The study also will evaluate the benefit of that feeding supplement in decreasing the rate of infection (in the blood or in the urine) and antibiotics use in those infants.

When babies are born, the digestive system (the gastrointestinal tract) is sterile. There are no bacteria residing in their gut. When babies start feeding, it is normal for the intestine to start growing several types of bacteria. These normal (good) bacteria are thought to be helpful in keeping the intestine healthy. This is not the case in premature infants. It takes premature infants a longer time to grow bacteria in their intestines and they have fewer numbers of bacteria. In addition, the bacteria premature infants grow are not the normal one that we see in healthy infants. Instead they grow unhealthy (bad) bacteria that can potentially play a role in causing infection in the blood and urine.

Adding the normal (good) bacteria to the breast milk or infant formula might help to protect premature babies from developing blood or urine infection. In addition, adding the good bacteria might be beneficial in terms of better tolerance to milk feeding. As a result, babies may have less episodes of feeding holding and have better weight gain. Two species of bacteria, called Lactobacillus and Bifidobacteria, have been used to study this in other studies of premature babies. These two species are the most plentiful bacteria seen in the bowels of full term babies.

Participation in the study involves enrolling premature babies to receive supplement to the feeding when he/she ready to feed. Babies will be randomly assigned to receive either a bacteria (probiotic) supplement or be fed without supplement. The supplement will be added to one feeding each day. Enrolled babies will continue to get the supplement for 6-10 week. Other than the feeding supplement, being in this study will not affect care.

The main outcomes of the study will be feeding tolerance and growth. Other complications associated with prematurity, on particular infection of either the gastrointestinal tract or the blood stream will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01164124
Study type Interventional
Source Vermont Oxford Network
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 2008
Completion date August 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Completed NCT03533712 - Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso. Phase 4
Completed NCT01461863 - DarDar Nutrition Study in HIV Breastfeeding Women N/A
Terminated NCT00607061 - Synthesis of Glutathione From Low Birth Weight Newborn Babies N/A
Recruiting NCT05576207 - BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR) N/A
Completed NCT03112018 - Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda N/A
Completed NCT05515211 - Diagnostic Accuracy of Foot Length in Predicting Preterm and Low Birth Weight Using Ultrasound Dating as The Gold Standard in a Rural District of Pakistan
Completed NCT02631343 - Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns N/A
Terminated NCT02090088 - Nplate® Pregnancy Exposure Registry N/A
Completed NCT00971815 - Effects of 3 Months of Selective Serotonin Reuptake Inhibitor (SSRI)-Treatment on Metabolism and Hypothalamic-pituitary-adrenal (HPA)-Axis in Young Men Born With Low Birth Weight N/A
Completed NCT03154177 - Group Antenatal/Postnatal Care in Rwanda N/A
Withdrawn NCT00582374 - Periodontal Disease and Preterm Birth N/A
Completed NCT00925925 - Epigenetic Markers of B-Cell Function in Low Birth Weight Infants N/A
Completed NCT03506698 - Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Completed NCT04908332 - Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home N/A
Completed NCT01115478 - Malaria in Pregnancy: Nutrition and Immunologic Effects N/A
Completed NCT00702767 - Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants N/A
Recruiting NCT05730569 - Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso
Completed NCT01487980 - Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants N/A
Completed NCT01235767 - Animal Source Food Supplement and Pregnancy in Vietnam N/A