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A clinical trial to evaluate duration of caffeine therapy for apnea of prematurity in preterm newborn.

Proportion of recurrence of Clinically Significant Apnea among neonates of gestational age 28 to 32 weeks on stopping Caffeine after an apnea free periods of 7 days :A Prospective Observational Study. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/09/057347
Enrollment
288
Registered
2023-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: stopping caffeine for apnea of prematurity after 7 days of apnea free period: caffeine therapy for all premature infants 28 to 32 weeks for the treatment of apnea will be stopped after

Sponsors

Nikhil Kumar
Lead Sponsor
Sobha kumar S
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All babies with birth gestation between 28 to 32 weeks on caffeine therapy.

Exclusion criteria

Exclusion criteria: antenatally detected congenital anomalies parents not giving consent

Design outcomes

Primary

MeasureTime frame
To estimate the proportion of infants between 28 to 32 weeks of gestational age who have clinically significant apnea on stopping caffeine after an apnea free period of 7 days. Clinically Significant Apnea defined as drop in saturation below 80% and any one of the following: (a) decrease in heart rate below 100/min. (b) Poor respiratory effort requiring PPV. (C)Need for o2 supplementation,HHFNC,CPAP,MV.(d)Restart of caffeine therpy by clinical team.Timepoint: From birth to 7 days of apnea free and off respiratory support.

Secondary

MeasureTime frame
1. To study the adverse effects related to caffeine among neonates. 2.To study the factors associated with clinically significant apnea after an apnea free period of 7 dayTimepoint: From birth till rooming in.

Countries

India

Contacts

Public ContactSobha Kumar S

Department Of Neonatolgy SAT Hospital Government Medical College Thiruvananthapuram

dr.sobhakumar@gmail.com9447151817

Outcome results

None listed

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