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Feeding Tolerance in Preterm Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
Information provided by:
Weill Medical College of Cornell University Identifier:
First received: February 7, 2007
Last updated: November 4, 2010
Last verified: November 2010

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.

Prematurity Feeding Intolerance

Study Type: Observational
Study Design: 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

Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment: 160
Study Start Date: February 2007
Estimated Study Completion Date: November 2008

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Anita Stola, Weill Cornell MC Identifier: NCT00450697     History of Changes
Other Study ID Numbers: 0608008682
Study First Received: February 7, 2007
Last Updated: November 4, 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 processed this record on July 19, 2017