Intraventricular Haemorrhage Neonatal
Conditions
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.
Interventions
DRUGAcetaminophen
The first group will receive acetaminophen as the following 1. 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. 2. Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
DRUGDextrose 5
The second group will receive placebo (D5W) as the following 1. Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes. 2. Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
Sponsors
King Saud Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Saudi Arabia
Contacts
Primary ContactMountasser Al-Mouqdafd, MD
Outcome results
None listed