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"Early Caffeine Discontinuation at 32 Weeks in Preterm Babies: Evaluating Apnea Recurrence at 32 vs. 34 Weeks The SAFE-CAFE Study"

Safety Assessment for Early Caffeine Weaning: SAFE-CAFE PILOT Randomised Controlled Trial - SAFE - CAFE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080833
Enrollment
186
Registered
2025-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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 discontinuation of caffeine citrate Group : Caffeine citrate will be stopped at 32 weeks of PMA. Control Intervention1: Conventional discontinuation of Group : Caffeine citrate wi

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
Lead Sponsor
Dr Phalguni Padhi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with a gestational age ranging from 26 to 31+6 weeks admitted in NICU and started on caffeine citrate (1. For treatment of apnea of prematurity, 2.All neonates admitted with respiratory distress requiring CPAP support)

Exclusion criteria

Exclusion criteria: 1.Major congenital anomalies 2.Grade III and grade IV Intraventricular hemorrhage 3.Drugs that can cause CNS depression - Antiepileptics, Morphine, Midazolam 4.Babies born with Birth Asphyxia 5.Baby on respiratory support higher than HFNC of 3L flow and 25% FiO2 6.Receiving treatment for Sepsis / PDA at the time of randomisation

Design outcomes

Primary

MeasureTime frame
Proportion of Infants with recurrence of Clinically Significant Apnea from Randomization till discharge in each of the two groupsTimepoint: Discharge of baby from hospital—

Secondary

MeasureTime frame
Gestation-specific day of recurrence of apnea post-caffeine discontinuation.Timepoint: Discharge of baby from hospital;Recurrence risk in subgroups based on gestational age at birth and severity of respiratory illness.Timepoint: discharge of baby from hospital;To assess the relationship between apnea recurrence after caffeine cessation and the number of days off CPAP before recurrence.Timepoint: Discharge of baby from hospital;Compare incidence of BPD in the two groupsTimepoint: Discharge from hospital;Occurrence of extrauterine growth restriction in the two groups.Timepoint: Discharge of baby from hospital;Risk of retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and abnormal cranial ultrasound findings.Timepoint: Till 3 months corrected ago follow up;Cost-effectiveness analysis for early discontinuation.Timepoint: Discharge from hospital;Neurodevelopmental outcome at 3 months post-caffeine discontinuation.Timepoint: Till 3 months corrected age follow up—

Countries

India

Contacts

Public ContactDr Abhishek S Gowdar

AIIMS RAIPUR

phalguni2011@gmail.com9040632169

Outcome results

None listed

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