Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Objective of this study are:
1) To determine if medication help extreme preterm infants to tolerate feeding better by reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1) Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study after parental consent. Infant would be blinded to care givers. Infants will be randomized to receive one of three medication for 7-14 days. If infants fail on one medication they will be allowed to crossover to other medication. Infant would be allowed to treat like other infants. Blindness can be broken if deem necessary by attending neonatologist.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo|
- Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.
- Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
This group of infant will not receive any medication but sugar water or placebo
The dose of sugar water is 1 ml per 8 hours.
Active Comparator: Metclopramide
This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.
Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
Other Name: reglan
Active Comparator: Erythromycin
mediaction used to treat feeding disorder
Dose of erythromycin is 1 miligram per kilogram every eight hours
- Weight below 1250 grams
- Age less than 14 days
- Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.
- GI malformation or perforation
- Genetic disorder
- Parents can't read English. After consent, if infants meet inclusion criteria, he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569633
|United States, Tennessee|
|East Tennessee State University|
|Johnson City, Tennessee, United States, 37604|
|Principal Investigator:||Darshan S Shah, MD||East Tennessee State University|