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Feeding Tolerance in Preterm Infants

This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, February 2008

Sponsored by: Weill Medical College of Cornell University
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00450697
  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

MedlinePlus related topics:   Premature Babies   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Groups/Cohorts
observation

Show detailed description  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

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


Responsible Party:   Weill Cornell MC ( Anita Stola )
Study ID Numbers:   0608008682
First Received:   February 7, 2007
Last Updated:   March 12, 2008
ClinicalTrials.gov Identifier:   NCT00450697
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 September 19, 2008




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