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Clinical Trial Summary

The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03024814
Study type Interventional
Source King Saud Medical City
Contact Mountasser Al-Mouqdafd, MD
Phone 00966539095090
Email m.almouqdad@ksmc.med.sa
Status Recruiting
Phase Phase 3
Start date October 2016
Completion date October 2018

See also
  Status Clinical Trial Phase
Completed NCT03019367 - Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 N/A