Feeding Tolerance in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00450697
First received: February 7, 2007
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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
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

Resource links provided by NLM:


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
Groups/Cohorts
observation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

very low birth weight premature infants with birth weight <= 1250g

Criteria

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 ClinicalTrials.gov identifier: NCT00450697

Contacts
Contact: Anita G Stola, MD 212 746-3530 anstola@hotmail.com
Contact: Jeffrey M Perlman, MD 212 746- 3530 jmp2007@med.cornell.edu

Locations
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    anstola@hotmail.com   
Contact: Jeffrey M Perlman, MD    212 746- 3530    jmp2007@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Anita G Stola, MD The New York Presbyterian Hospital-Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Anita Stola, Weill Cornell MC
ClinicalTrials.gov Identifier: NCT00450697     History of Changes
Other Study ID Numbers: 0608008682
Study First Received: February 7, 2007
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014