Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

Inclusion Critera: 1. Weight below 1250 grams 2. Age less than 14 days 3. 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. Exclusion Criteria 1. GI malformation or perforation 2. Genetic disorder 3. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01569633
Study type	Interventional
Source	East Tennessee State University
Contact
Status	Withdrawn
Phase	N/A
Start date	October 2011
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03445689` - Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Completed	`NCT03245723` - Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)	N/A
Active, not recruiting	`NCT03575897` - Serial Assessment of Body Fat Accrual in Very Preterm Infants	N/A
Completed	`NCT03082313` - Movement-based Infant Intervention	N/A
Completed	`NCT03696758` - Improving Right Ventricular Function in Young Adults Born Preterm	Phase 2
Terminated	`NCT03532555` - Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia	N/A
Completed	`NCT03230032` - Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy	N/A
Recruiting	`NCT03693287` - Personalized vs Standardized PN for Preterm Infants >1250g	Phase 4
Terminated	`NCT03542812` - L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia	Early Phase 1
Completed	`NCT03434743` - Non-nutritive Sucking and Breastfeeding in Preterm Infants	N/A
Active, not recruiting	`NCT03168516` - Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants	Phase 3
Completed	`NCT03357458` - Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age	N/A
Recruiting	`NCT03521063` - Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.	Phase 4
Recruiting	`NCT03501485` - Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.
Completed	`NCT03280381` - Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding	N/A
Completed	`NCT03586856` - Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment	N/A
Completed	`NCT03333161` - Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2	N/A
Completed	`NCT03333174` - Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3	N/A
Active, not recruiting	`NCT03558737` - Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants	N/A