Feeding Disorder, Infant,Premature, Nutrition Disorder
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGMetclopramide
Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
DRUGErythromycin
Dose of erythromycin is 1 miligram per kilogram every eight hours
DRUGplacebo
The dose of sugar water is 1 ml per 8 hours.
Sponsors
East Tennessee State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL | 24 MONTHS | Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. | 24 months | Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia, |
Countries
United States
Outcome results
None listed