Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Feeding Disorder Nutrition Disorder Infant,Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Placebo

This group of infant will not receive any medication but sugar water or placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The dose of sugar water is 1 ml per 8 hours.

Metclopramide

This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.

Group Type ACTIVE_COMPARATOR

Metclopramide

Intervention Type DRUG

Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.

Erythromycin

mediaction used to treat feeding disorder

Group Type ACTIVE_COMPARATOR

Erythromycin

Intervention Type DRUG

Dose of erythromycin is 1 miligram per kilogram every eight hours

Interventions

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Metclopramide

Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.

Intervention Type DRUG

Erythromycin

Dose of erythromycin is 1 miligram per kilogram every eight hours

Intervention Type DRUG

placebo

The dose of sugar water is 1 ml per 8 hours.

Intervention Type DRUG

Other Intervention Names

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reglan

Eligibility Criteria

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Inclusion Criteria

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.