Feeding Tolerance in Preterm Infants

Status unconfirmed

Conditions studied: Prematurity, Feeding Intolerance

In brief

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.

Key facts

Study ID

NCT00450697

Run by

Weill Medical College of Cornell University

People needed

160

Starts

2007-02-01

Expected to finish

2008-11-01

Last updated by the study team

2010-11-05

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Parental request
• If feeding cannot be initiated prior to day of life 10
• NEC requiring surgery
• Prolonged (> 3days) intolerance to the feeding regimen

Where it is running

• New York Presbyterian Hospital; Weill Cornell Medical College; Department of Pediatrics; Division of Neonatology — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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