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Early versus Late stoppage of Caffeine Citrate medication and Short versus Standard monitoring of babies post stoppage of Caffeine Citrate in small babies.

Early versus late discontinuation of caffeine therapy and short versus standard monitoring for apnea post discontinuation of caffeine therapy in preterm infants a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089772
Enrollment
90
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Early discontinuation of caffeine and standard monitoring duration(group 1/test group): Caffeine will be discontinued between 32 1/7 to 33 6/7 weeks and will be monitored for apnea free

Sponsors

Anitha Ananthan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants born at less than 32 weeks gestation who require respiratory support within the first 7 days and on caffeine therapy

Exclusion criteria

Exclusion criteria: 1. Infants with major congenital malformations 2. Infants with grade 3 or grade 4 IVH.

Design outcomes

Primary

MeasureTime frame
Recurrence of apnoea after stopping caffeine therapyTimepoint: 1 week post caffeine therapy

Secondary

MeasureTime frame
Need for restarting caffeine therapy.Timepoint: 1 day to 1 week after stopping caffeine;Duration of caffeine therapyTimepoint: 4 to 8 weeks;Need for mechanical ventilation after treatment discontinuation.Timepoint: 1 week;Need for non-invasive respiratory support (continuous positive airway pressure [ CPAP], nasal intermittent positive pressure ventilation {NIPPV}, nasal high-flow cannulae) within one week of treatment discontinuation.Timepoint: within one week of treatment discontinuation;Number of episodes of apnea ( defined as interruption of breathing for more than 20 seconds or shorter duration if associated with bradycardia or skin colour change (pallor/cyanosis)Timepoint: in the seven days after treatment discontinuation;All-cause mortalityTimepoint: 2 weeks post caffeine discontinuation;Number of days of respiratory supportTimepoint: 4 to 8 weeks;Bronchopulmonary dysplasiaTimepoint: 4 to 8 weeks;NEC stage 2 or moreTimepoint: from end of first week till 8 weeks;ROP requiring treatmentTimepoint: 3 weeks till 12 weeks;Duration of hospital stayTimepoint: 8 to 12 weeks;Long term neurodevelopmental outcome (BSID-4)Timepoint: 1 year of age

Countries

India

Contacts

Public ContactDr Anitha Ananthan

Seth GS Medical College and KEMH

ani.gem81@gmail.com02224107138

Outcome results

None listed

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