Feeding Tolerance in Preterm Infants
Recruitment status was Recruiting
|First Received Date ICMJE||February 7, 2007|
|Last Updated Date||November 4, 2010|
|Start Date ICMJE||February 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00450697 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Feeding Tolerance in Preterm Infants|
|Official Title ICMJE||Feeding Tolerance in Preterm Infants: Randomized Trial of Bolus Feeding Every 4 Hours Versus Every 3 Hours|
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.
In premature infants feeding tolerance is limited due to immaturity of gastrointestinal tract. Motor patterns of the gastrointestinal tract differ greatly in preterm infants as compared to adults. These differences in gastrointestinal motor function in premature neonates translates into less efficient gastric emptying and slower intestinal transit time. It usually manifests as residual feeds in the stomach prior to the next scheduled feeding and may be associated with abdominal distention, bile-staining aspirates, or lack of stooling. In most instances the gastric residuals are benign and relate to immature gastrointestinal motility, however they may also be an early indication of bowel obstruction, ileus or necrotizing enterocolitis. Thus, feeding intolerance often leads to temporary cessation of feeds, and prolongs the time to reach full feeds, as well as the time on parenteral nutrition (which predisposes the infants to nosocomial infection, hepatic dysfunction), and prolonged hospitalization.
Achievement of adequate enteral nutrition, as soon as possible after birth is the ultimate goal for all low birth weight infants (<1250 gm); however the best methods by which sufficient enteral nutrition can be provided remain controversial.
A number of feeding strategies are practiced. In our Neonatal ICU feeds are initiated by boluses and infants are being fed either every 3 hours or every 4 hours. A review of the literature (2006) revealed that there was no study comparing those two methods of feeding. We hypothesize that very low birth weight infants (≤1250 gm) will tolerate feedings better when introduced every 4 hours instead every 3 hours, by providing sufficient time for gastric emptying.
We propose to conduct this prospective, randomized, clinical trial to determine whether intermittent bolus gavage feedings every 4 hours leads to better feeding tolerance than intermittent bolus gavage feedings every 3 hours in very low birth weight infants < 1250grams birth weight.
Very low birth weight infants fed by intermittent bolus gavage every 4 hours will achieve full enteral feeding (120 kcal/kg per day) at an earlier postnatal age and have less feeding intolerance than infants fed every 3 hours.
Intermittent bolus gavage feeding every 4 hours will improve feeding tolerance, cause less need for parenteral nutrition and its major complication - cholestasis.
Primary study endpoint:
Secondary study endpoint:
To determine whether infants fed by intermittent gastric bolus gavage every 4 hours will have less feeding intolerance and reach full feeds at least 2 days earlier than infants fed every 3 hours.
To determine if feeding every 4 hours will facilitate discontinuation of parenteral nutrition at an earlier postnatal age and result in less incidence of cholestasis.
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
Infant will be withdrawn from the study for the following reasons:
Parental request If feeding cannot be initiated prior to day of life 10 NEC requiring surgery Prolonged (> 3days) intolerance to the feeding regimen
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
very low birth weight premature infants with birth weight <= 1250g
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||observation|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||160|
|Estimated Completion Date||November 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 2 Months|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00450697|
|Other Study ID Numbers ICMJE||0608008682|
|Has Data Monitoring Committee||No|
|Responsible Party||Anita Stola, Weill Cornell MC|
|Study Sponsor ICMJE||Weill Medical College of Cornell University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Weill Medical College of Cornell University|
|Verification Date||November 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP