Recruiting

Feeding Methods

Sponsor:

Weill Medical College of Cornell University

Code:

NCT00450697

Conditions

Prematurity

Feeding Intolerance

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Prematurity

Feeding Intolerance

Study ID

NCT00450697

Start date

Feb, 2007

Status verified date

Nov, 2010

Completion date

Nov, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

observation

Central Contacts and Locations

Central contacts

Locations

New York Presbyterian Hospital; Weill Cornell Medical College; Department of Pediatrics; Division of Neonatology

Recruiting

New York, New York, United States, 10021

Contacts

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Nov 5, 2010

Last verified

Nov, 2010

Keywords

  • Feeding intolerance in premature infants
  • Bolus feeding every 4 hours versus every 3 hours
  • Feeding method in premature infants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2010-11-05.