Use of Prokinetics in Early Enteral Feeding in Preterm Infants

East Tennessee State University

Status: Withdrawn

Conditions: Infant,Premature; Nutrition Disorder; Feeding Disorder

Treatments: Drug: Metclopramide; Drug: Erythromycin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01569633

ft2011ep

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Metclopramide

Active Comparator group

Description:

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

Treatment:

Drug: Metclopramide

Erythromycin

Active Comparator group

Description:

mediaction used to treat feeding disorder

Treatment:

Drug: Erythromycin