Document Detail

A phase 1 trial testing an enteral solution patterned after human amniotic fluid to treat feeding intolerance.
MedLine Citation:
PMID:  16618478     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Feeding intolerance is a common problem in neonates; in some cases it may be related to atrophic changes in the small bowel mucosa. In these infants, feeding tolerance might improve after oral administration of enterocyte growth factors in a sterile, isotonic, noncaloric solution patterned after human amniotic fluid. STUDY DESIGN: Ten infants who met the study criteria for feeding intolerance were enrolled in this pilot trial. The test solution was administered, 2.5 mL/kg every 3 hours, until 80 mL/kg/day of milk feedings were tolerated, or for a maximum of 7 days. When milk feedings were prescribed, they were mixed with the test solution. Volumes of milk feedings were increased in amounts determined by the attending neonatologist and neonatal nurse practitioner. The outcome was the net average enteral kilocalories per kilogram of body weight per day (kcal/kg/day) for 3 periods: (1) the 3 days before the test treatment was begun, (2) the days the test treatment was administered, and (3) the 7 days following cessation of the test treatment. RESULTS: At study entry the infants' chronological ages ranged from 3 to 65 days. All infants tolerated the test solution, which was given for a mean of 5 days (range 3 to 7 days). During that period, the infants received more enteral calories (mean 18 kcal/kg/day, range 1 to 32) than during the preceding 3 day period (mean 3 kcal/kg/day, range 0 to 7, P < 0.05). During the 7 days following the test treatment the infants received 87 enteral kcal/kg/day (range 11 to 109, P < 0.02 compared to the treatment period). CONCLUSIONS: In this Phase 1 pilot trial, 10 heterogeneous infants in the neonatal intensive care unit with feeding intolerance had a significant increase in milk feedings after treatment with a sterile, isotonic, noncaloric solution patterned after human amniotic fluid.
Cindy K Barney; Nancene Purser; Robert D Christensen
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article    
Journal Detail:
Title:  Advances in neonatal care : official journal of the National Association of Neonatal Nurses     Volume:  6     ISSN:  1536-0903     ISO Abbreviation:  Adv Neonatal Care     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-04-18     Completed Date:  2006-09-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101125644     Medline TA:  Adv Neonatal Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  89-95     Citation Subset:  IM    
Intermountain Health Care Neonatology Collaborative Research Group, Ogden, Utah, USA.
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MeSH Terms
Amniotic Fluid*
Enteral Nutrition*
Gastrointestinal Diseases / therapy*
Growth Substances / therapeutic use
Infant, Newborn
Infant, Premature*
Pilot Projects
Recombinant Proteins / therapeutic use
Reg. No./Substance:
0/Growth Substances; 0/Recombinant Proteins

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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