Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.

Detailed Description
-----------------
It will be a double-blind randomized control trial, single center. The study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below). Infants will be randomized to equal-sized groups using block randomization with blocks of four. Stratified randomization for gender and gestational age will be included in the randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.

Official Title
-----------------
Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Conditions
-----------------
Intraventricular Haemorrhage Neonatal

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Dextrose 5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature baby less than or equal 32 week and birth weight less than or equal 1500 g Exclusion Criteria: Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetaminophen group<br>Babies who took acetaminophen | Drug: Acetaminophen<br>* The first group will receive acetaminophen as the following Loading dose: 20 mg/kg in the first 12-24 hours To be diluted in D5W up to 3-5 ml and to be infused over 15 minutes. Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.<br>* Other names: Paracetamol;|
| Experimental: Placebo group (Dextrose 5)<br>Babies who took placebo | Drug: Dextrose 5<br>* The second group will receive placebo (D5W) as the following Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes. Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.<br>* Other names: Dextrose 5%;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo. |  | within the first week of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of neonatal sepsis in the premature babies who received acetaminophen |  | Corrected 40 weeks of gestational age or time of discharge will be used | 
| The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen |  | Corrected 40 weeks of gestational age or time of discharge will be used | 
| The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen |  | Corrected 40 weeks of gestational age or time of discharge will be used |