Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Study Overview
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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.

Detailed Description
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Inclusion Critera: 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. Exclusion Criteria 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.

Official Title
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Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo

Conditions
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Feeding Disorder, Nutrition Disorder, Infant,Premature

Intervention / Treatment
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* Drug: Metclopramide
* Drug: Erythromycin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria 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.

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This group of infant will not receive any medication but sugar water or placebo | Drug: placebo<br>* The dose of sugar water is 1 ml per 8 hours.<br>|
| Active Comparator: Metclopramide<br>This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs. | Drug: Metclopramide<br>* Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.<br>* Other names: reglan;|
| Active Comparator: Erythromycin<br>mediaction used to treat feeding disorder | Drug: Erythromycin<br>* Dose of erythromycin is 1 miligram per kilogram every eight hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL | Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding. | 24 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. | Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia, | 24 months |