Feeding Tolerance in Preterm Infants

NCT00450697 | Unknown

• 1 other identifier: 0608008682
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Study Arms (1)

observation

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Parental request
• If feeding cannot be initiated prior to day of life 10
• NEC requiring surgery
• Prolonged (\> 3days) intolerance to the feeding regimen

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

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

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anita G Stola, MD

  The New York Presbyterian Hospital-Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita G Stola, MD

CONTACT

212 746-3530; anstola@hotmail.com

Jeffrey M Perlman, MD

CONTACT

212 746- 3530; jmp2007@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: March 22, 2007
• Study Start: February 1, 2007
• Study Completion: November 1, 2008
• Last Updated: November 5, 2010

Record last verified: 2010-11

Locations

US (1)