Study to compare higher dose of a drug called caffeine citrate for managing a condition occuring in newborn babies called apnea of prematurity which invloves improving breathing control.

A randomized control study comparing two doses of caffeine for apnea of prematurity in tertiary care center. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074667

Enrollment

120

Registered

2024-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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: High Dose Caffeine citrate: Loading dose of 40mg/kg followed by 20mg/kg /day of caffeine citrate for apnea of prematurity till the neonate remains apnea free for 7 days Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: All new-borns intramuraly delivered with 30 to 34 week GA admitted in Neonatal intensive care, Department of Paediatrics, R.N.T. Medical College, Udaipur, Rajasthan.

Exclusion criteria

Exclusion criteria: Severe respiratory distress syndrome,Neonates requiring mechanical ventilation ,Sepsis (culture proven),Neonates with congenital malformation, Maternal drug use (MgSO4, morphine),Severe intra-ventricular haemorrhage,Newborns requiring Resuscitation,Parents refusing for consent

Design outcomes

Primary

Measure	Time frame
To compare frequency of apnea and the duration of days with apneic episodes in a higher and standard dose of Caffeine for Apnea in PrematurityTimepoint: daily and to stop once the neonate remains apnea free for 7 days.	—

Secondary

Measure	Time frame
To compare duration of non-invasive ventilation & duration of oxygen therapy (nasal prong oxygen),time to reach full enteral feeds & adverse effects of caffeine citrate duration of hospital stay Timepoint: during discharge & once the neonate becomes stable at room air	—

Countries

India

Contacts

Public ContactDr Mohammad Asif

R.N.T Medical college

rntianasif@gmail.com9785056044

Outcome results

None listed

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