Feeding Tolerance in Preterm Infants
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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 |
| 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 |
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| Contact: Anita G Stola, MD | 212 746-3530 | anstola@hotmail.com |
| Contact: Jeffrey M Perlman, MD | 212 746- 3530 | jmp2007@med.cornell.edu |
| 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 | |
| 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 June 17, 2013