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A clinical trial to evaluate the duration of caffeine therapy for apnea of prematurity

Comparison of two durations of caffeine therapy on clinically significant apnea - A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007559
Enrollment
174
Registered
2016-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: null- Apnea of Prematurity

Interventions

Intervention1: Short duration caffeine therapy-Stopping Caffeine for Apnea of Prematurity after 7 apnea free days.: Caffeine therapy in all premature infants for treatment of apnea will be stopped aft

Sponsors

Kerala Institute of Medical Science
Lead Sponsor
Dr Naveen Jain
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All babies with birth gestation between 26 â?? 32 weeks, on caffeine therapy. Indications for caffeine therapy: 1)As treatment for apnea of prematurity. 2)Prophylactic caffeine therapy in extremely low birth weight infants (birth weight below 1000 g) to avoid intubation and mechanical ventilation, or to enhance extubation. 3)Periextubation caffeine for infants less than 32 weeks and those intubated for RDS.

Exclusion criteria

Exclusion criteria: â?¿Major congenital anomalies â?¿Grade 111 or 1V Intraventricular Hemorrhage (IVH). â?¿On drugs that can cause central nervous system depression â?? morphine, midazolam, antiepileptic drugs (AED)

Design outcomes

Primary

MeasureTime frame
Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.Timepoint: till rooming in.

Secondary

MeasureTime frame
Abnormal USG cranium at 36-40 weeks Timepoint: 36-40 weeks;All cause mortality during initial hospitalizationTimepoint: during hospital stay;EUGR (extrauterine growth retardation, Z from birth weight) on gender specific Fentons chartTimepoint: at discharge;Gestation specific day of recurrence of apnea from the day caffeine is stopped. Timepoint: till rooming in.;NEC/feed intolerance / tachycardia requiring decrease in caffeine doseTimepoint: till rooming in;Neurological Outcome at discharge assessed by Hammersmith examinationTimepoint: at discharge;Oxygen dependency at postnatal day 28Timepoint: 28 days postnatal age;Proportion of babies requiring interventions for apnea of prematurity , after excluding those with apnea secondary to new sepsis, primary pulmonary pathology (pneumthorax, collapse, pulmonary hemorrhage, pneumonia), anemia, hyponatremia, preterm brain injury (USG cranium / MRI â?? PVL stage 2 or more), GERD requiring therapy, upper airway problems requiring intervention, inborn errors of metabolismTimepoint: till rooming in;Recurrence risk of apnea in subgroup of babies with minimal vs moderate to severe respiratory illness after birthTimepoint: till rooming in.;ROP requiring laser treatment Timepoint: till requiring treatment

Countries

India

Contacts

Public ContactRaj Prakash

Kerala Institute of Medical Science

naveen_19572@hotmail.com9387814568

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026