Randomized controlled trial (RCT) comparing between High versus Standard dose caffeine citrate for apnoea in prematurity

Phase 2

Recruiting

• Conditions: Apnoea of prematurity; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619001708145
• Lead Sponsor: Hospital Universiti Sains Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1.Prematurity 26 to 32 completed weeks admitted to Neonatal Intensive Care Unit Hospital
Universiti Sains Malaysia
2.24 hours periextubation period if ventilated

Exclusion Criteria

1.Hydrops fetalis
2.Major congenital anomaly (Major malformations causing significant functional or
cosmetic impairment or being life-limiting. ‘Examples of major malformations include
neural tube defect, hypoplastic left heart, ventral wall defect, and craniofacial cleft’)
3.Major neurological condition; examples Grade 3 or 4 intraventricular haemorrhage
4.Contraindication on starting oral medication (Examples Necrotising Enterocolitis,
bowel pathology like malrotation, Hirschprung disease)

Withdrawal criteria
1.Premature baby who developed Supraventricular tachycardia (SVT) or persistent
tachycardia during the course of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified