Feeding Tolerance in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450697
Recruitment Status : Unknown
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : March 22, 2007
Last Update Posted : November 5, 2010
Information provided by:
Weill Medical College of Cornell University

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.

Condition or disease
Prematurity Feeding Intolerance

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feeding Tolerance in Preterm Infants: Randomized Trial of Bolus Feeding Every 4 Hours Versus Every 3 Hours
Study Start Date : February 2007
Estimated Study Completion Date : November 2008


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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
very low birth weight premature infants with birth weight <= 1250g

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450697

Contact: Anita G Stola, MD 212 746-3530
Contact: Jeffrey M Perlman, MD 212 746- 3530

United States, New York
New York Presbyterian Hospital; Weill Cornell Medical College; Department of Pediatrics; Division of Neonatology Recruiting
New York, New York, United States, 10021
Contact: Anita G Stola, MD    212-746-3530   
Contact: Jeffrey M Perlman, MD    212 746- 3530   
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Anita G Stola, MD The New York Presbyterian Hospital-Weill Medical College of Cornell University

Responsible Party: Anita Stola, Weill Cornell MC Identifier: NCT00450697     History of Changes
Other Study ID Numbers: 0608008682
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: November 5, 2010
Last Verified: November 2010

Keywords provided by Weill Medical College of Cornell University:
Feeding intolerance in premature infants
Bolus feeding every 4 hours versus every 3 hours
Feeding method in premature infants