Feeding Tolerance in Preterm Infants
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|ClinicalTrials.gov 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
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|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00450697
|Contact: Anita G Stola, MD||212 firstname.lastname@example.org|
|Contact: Jeffrey M Perlman, MD||212 746- email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jeffrey M Perlman, MD 212 746- 3530 email@example.com|
|Principal Investigator:||Anita G Stola, MD||The New York Presbyterian Hospital-Weill Medical College of Cornell University|