Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450697
Status:
UNKNOWN
Last Update Posted:
2010-11-05
First Post:
2007-02-07
Brief Title:
Feeding Tolerance in Preterm Infants
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Feeding Tolerance in Preterm Infants Randomized Trial of Bolus Feeding Every 4 Hours Versus Every 3 Hours
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infants 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
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 infants 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
Detailed Description:
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
Primary Hypothesis
Very low birth weight infants fed by intermittent bolus gavage every 4 hours will achieve full enteral feeding 120 kcalkg per day at an earlier postnatal age and have less feeding intolerance than infants fed every 3 hours
Secondary Hypothesis
Intermittent bolus gavage feeding every 4 hours will improve feeding tolerance cause less need for parenteral nutrition and its major complication - cholestasis
Study Design
Prospective randomized clinical study with recruitment at NY Presbyterian Hospital Cornell Medical Center
Written informed consent will be obtained from one or both parents prior to enrollment of each patient
Primary study endpoint
Days to reach full feeds of 120 mlkg per day
Incidence of feeding intolerance
Secondary study endpoint
Days on parenteral nutrition parenteral nutrition is discontinued when an infant tolerates enteral feeding of 100 mlkg per day
Incidence and severity of cholestatic jaundice
Primary objective
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
Secondary objectives
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
Treatment plan
Feeding Protocol
Infants who meet all of the above criteria will be randomly assigned using sealed opaque envelopes to either every the 3 hour or every 4 hour feeding groups
Nasogastric feeding will be initiated on the third to fifth postnatal day provided the infants cardiorespiratory status is stable
Bolus feeding over 30 to 60 min will be given as per usual clinical practice
Expressed breast milk is the nutrition of choice If not available Premature Formula of 24 kcal30 ml will be used as per usual clinical practice
Feeding will be started and advanced in daily increments depending on infants weight
500 gm to 750 gm - 10 mlkg per day
751gm to 1000gm - 15 mlkg per day
1001 gm to 1250gm - 20 mlkg per day
Gastric residual will be measured prefeed every 3 or 4 hours
All feeding-related clinical decisions when to withhold feedings will be up to the attending physicians discretion
Parenteral nutrition including lipid emulsion will be started on days 1 or 2 and continued until each infant tolerates enteral feeding of 100 mlkg per day
Successful achievement of full enteral feeding is defined as the ability to tolerate enteral feedings of 110-120 mlkg per day for at least 48 hours
Daily weight intake and output number of stools number of guaiac positive stools number of hours that feedings were withheld episodes of apnea and bradycardia will be recorded
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
Primary Hypothesis
Very low birth weight infants fed by intermittent bolus gavage every 4 hours will achieve full enteral feeding 120 kcalkg per day at an earlier postnatal age and have less feeding intolerance than infants fed every 3 hours
Secondary Hypothesis
Intermittent bolus gavage feeding every 4 hours will improve feeding tolerance cause less need for parenteral nutrition and its major complication - cholestasis
Study Design
Prospective randomized clinical study with recruitment at NY Presbyterian Hospital Cornell Medical Center
Written informed consent will be obtained from one or both parents prior to enrollment of each patient
Primary study endpoint
Days to reach full feeds of 120 mlkg per day
Incidence of feeding intolerance
Secondary study endpoint
Days on parenteral nutrition parenteral nutrition is discontinued when an infant tolerates enteral feeding of 100 mlkg per day
Incidence and severity of cholestatic jaundice
Primary objective
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
Secondary objectives
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
Treatment plan
Feeding Protocol
Infants who meet all of the above criteria will be randomly assigned using sealed opaque envelopes to either every the 3 hour or every 4 hour feeding groups
Nasogastric feeding will be initiated on the third to fifth postnatal day provided the infants cardiorespiratory status is stable
Bolus feeding over 30 to 60 min will be given as per usual clinical practice
Expressed breast milk is the nutrition of choice If not available Premature Formula of 24 kcal30 ml will be used as per usual clinical practice
Feeding will be started and advanced in daily increments depending on infants weight
500 gm to 750 gm - 10 mlkg per day
751gm to 1000gm - 15 mlkg per day
1001 gm to 1250gm - 20 mlkg per day
Gastric residual will be measured prefeed every 3 or 4 hours
All feeding-related clinical decisions when to withhold feedings will be up to the attending physicians discretion
Parenteral nutrition including lipid emulsion will be started on days 1 or 2 and continued until each infant tolerates enteral feeding of 100 mlkg per day
Successful achievement of full enteral feeding is defined as the ability to tolerate enteral feedings of 110-120 mlkg per day for at least 48 hours
Daily weight intake and output number of stools number of guaiac positive stools number of hours that feedings were withheld episodes of apnea and bradycardia will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None