Comparison of different doses of caffeine (respiratory stimulant) to prevent intermittent episodes of cessation of breathing and low saturation/heart rate in preterm babies

High (10mg/kg/day) vs. Standard maintenance dose (5mg/kg/day) of caffeine on the incidence of caffeine therapy failure in preterm infants of less than 32 weeks gestational age: An open label, parallel group, superiority randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058930

Enrollment

Registered

2023-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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: Caffeine citrate: 20mg/kg loading dose followed by 10mg/kg/day maintenance dose initiated 24 hours later. Drug will be continued atleast till 34 weeks of Postmenstrual age (PMA) or even

Eligibility

Inclusion criteria

Inclusion criteria: All neonates who receive caffeine prophylactically ( <28 weeks of gestation) or for treatment of apnea of prematurity in <32 weeks gestation would be included once the treating clinical team initiates caffeine

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations 2. Antenatally diagnosed chromosomal disorders 3. Infants with airway anomalies 4. Neonates on mechanical ventilation at the time of initiation of caffeine citrate

Design outcomes

Primary

Measure	Time frame
To compare the incidence of caffeine therapy failure between two maintenance doses in the first 2 weeks post initiation of therapy for apnea of prematurityTimepoint: First 2 weeks post initiation of caffeine	—

Secondary

Measure	Time frame
1. Number of investigative workups done for evaluation of secondary causes of apnea while on maintenance caffeine therapy till death/discharge/caffeine stoppage 2. No of episodes of hypoxemia(Spo2 3. Cumulative dose in mg of caffeine the neonate received till death/discharge/caffeine stoppage 4. Duration of respiratory support 5. Duration of hospital stay 6. Incidence of al cause failure of caffeine therapy in the first 2 weeks of initiation of therapy for apnea of prematurityTimepoint: Till death/discharge/ caffeine stoppage	—

Measure

Time frame

1. Number of investigative workups done for evaluation of secondary causes of apnea while on maintenance caffeine therapy till death/discharge/caffeine stoppage 2. No of episodes of hypoxemia(Spo2 3. Cumulative dose in mg of caffeine the neonate received till death/discharge/caffeine stoppage 4. Duration of respiratory support 5. Duration of hospital stay 6. Incidence of al cause failure of caffeine therapy in the first 2 weeks of initiation of therapy for apnea of prematurityTimepoint: Till death/discharge/ caffeine stoppage

—

Countries

India

Contacts

Public ContactDr Gurram Sai Srinivas

AIIMS, New Delhi

dranuthukral@gmail.com9891392188

Outcome results

None listed

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