Clinical Trial: Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: King Saud Medical City

Current Primary Outcome: The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo. [ Time Frame: within the first week of age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidence of neonatal sepsis in the premature babies who received acetaminophen [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Corrected 40 weeks of gestational age or time of discharge will be used ]


Original Secondary Outcome: Same as current

Information By: King Saud Medical City

Dates:
Date Received: November 14, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: January 14, 2017
Last Verified: January 2017