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Early versus Conventional discontinuation of Caffeine therapy for premature babies with apnea

Early versus Conventional discontinuation of Caffeine therapy for Apnea of Prematurity- A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064781
Enrollment
92
Registered
2024-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P284- Other apnea of newborn

Interventions

Intervention1: Early: Caffeine therapy in all preterm neonates for apnea of prematurity will be stopped after they are apnea free and off respiratory support for 5 days and has attained the Post-Menst

Sponsors

National Institute of Medical Science and Research Jaipur Rajasthan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm infants (both inborn and outborn) with gestational age 26 to 32 weeks and on caffeine therapy for apnea of prematurity fulfilling all the criteria below a)Neonate with birth weight =1250gm or = 30 weeks gestational age or Neonate with 30-32weeks gestational age and on Respiratory support receiving caffeine b)Babies whose parents have given informed consent

Exclusion criteria

Exclusion criteria: Any one of the following a)Expired before eligibility b)Those with major congenital anomalies (antenatally diagnosed or visible at birth) c)Grade III or IV intraventricular haemorrhage d)Newborn who has not been weaned off respiratory support till 32+2weeks of Post Menstrual Age (PMA)

Design outcomes

Primary

MeasureTime frame
The proportion of neonates with the recurrence of apnea after stopping caffeine therapy in both groups will be comparedTimepoint: Death or discharge—

Secondary

MeasureTime frame
The following clinical outcomes will be compared in both the groups after stoppage of caffeine therapy: 1. Median day of occurrence of apnea after stopping caffeine 2. Post menstrual age at the last dose of caffeine 3. Duration of caffeine therapy 4. Proportion of neonates with feed intolerance 5. Time to regain birth weight 6. Proportion of neonates requiring re-initiation of respiratory support 7. Proportion of neonates with neonatal morbidities including BPD, NEC, PDA and ROP 8. All cause mortality 9. Duration of hospital stay 10. Adverse effect requiring reduction of caffeine doseTimepoint: Death or discharge—

Countries

India

Contacts

Public ContactGunjana Kumar

National Institute of Medical Science and Research, Jaipur, Rajasthan

gunjanakumar@gmail.com7073077130

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026