Prematurity Clinical Trial
Official title:
Feeding Tolerance in Preterm Infants: Randomized Trial of Bolus Feeding Every 4 Hours Versus Every 3 Hours
Premature infants, especially those less than 1250 gm at birth are extremely difficult to
feed. For unknown physiologic reasons oral feeding also called enteral feeding is not well
tolerated in these immature babies. Because of this challenge these infants require
intravenous fluids solution called parenteral nutrition (TPN). Intravenous nutrition is
inadequate because it cannot supply sufficient calories for growth both of body and brain.
The composition of intravenous nutrition is also toxic to the liver.
For those reasons it is very important to achieve adequate enteral nutrition in premature
infants as soon as possible after birth. However the best feeding method for those babies
has not been defined.
Since premature babies are unable to suck and swallow properly, feeding is administered by a
tube inserted into the infant's stomach. The timing between feeds is inconsistent. Some
infants are fed every 3 hours, whereas others are fed every 4 hours.
The purpose of this study is to determine which feeding method is better. We hypothesize
that feeding every 4 hours by allowing more time for digestion will improve feeding
tolerance in premature infants. In addition it will also facilitate discontinuation of TPN
sooner, thus causing less side effects.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | November 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 2 Months |
Eligibility |
Inclusion Criteria: - Weight = 1250 gm - Sufficient stability to start early (day 3-5) enteral feedings - Appropriate weight for gestational age - Infants receiving ventilatory support and those with indwelling umbilical arterial catheters will be included - Absence of major congenital malformations Exclusion Criteria: - Parental request - If feeding cannot be initiated prior to day of life 10 - NEC requiring surgery - Prolonged (> 3days) intolerance to the feeding regimen |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | New York Presbyterian Hospital; Weill Cornell Medical College; Department of Pediatrics; Division of Neonatology | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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