Comparison of two caffeine therapy protocols in premature babies

“Symptom based ? compared to “current consensus based ? duration of caffeine therapy in neonates (26-31 weeks of gestation) for apnoea of prematurity: A non-inferiority randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057692

Enrollment

Registered

2023-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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 Health Condition 2: J989- Respiratory disorder, unspecified

Interventions

Intervention1: Symptom based duration of caffeine therapy: Caffeine will be stopped once the baby is greater than 32 weeks of gestation and apnea free and off respiratory support for 7 days. Control I

Eligibility

Inclusion criteria

Inclusion criteria: All live neonates born to mothers of greater than 18 years of age and born between 26 to 31 weeks of gestation who are started on caffeine therapy for apnea of prematurity

Exclusion criteria

Exclusion criteria: 1.Intra Ventricular hemorrhage Grade II and beyond 2. Major gross congenital anomalies at birth

Design outcomes

Primary

Measure	Time frame
To compare the occurrence rate of apnoea in “symptom based ? with “current consensus based ? duration of caffeine therapy in neonates of 26-31 weeks of gestation for apnoea of prematurity.Timepoint: Daily till discharge or death	—

Secondary

Measure	Time frame
All cause mortalityTimepoint: Daily till discharge or death;Mean duration of hospital stayTimepoint: Daily till discharge or death;Mean serum levels of caffeineTimepoint: At D5 of starting caffeine therapy & D7 of stoppage of caffeine;Median day of apnoea occurrenceTimepoint: Daily till discharge or death;Proportion of neonates requiring re-initiation of respiratory supportTimepoint: Daily till discharge or death;Proportion of neonates with Bronchopulmonary dysplasia (BPD), Necrotizing enterocolitis (NEC), Patent Ductus Arteriosus (PDA), Retinopathy of Prematurity (ROP), Extra Uterine Growth Restriction (EUGR)Timepoint: Daily till discharge or death;Proportion of neonates with feed intoleranceTimepoint: Daily till discharge or death;Time to regain birth weightTimepoint: Daily till discharge or death	—

Measure

Time frame

All cause mortalityTimepoint: Daily till discharge or death;Mean duration of hospital stayTimepoint: Daily till discharge or death;Mean serum levels of caffeineTimepoint: At D5 of starting caffeine therapy & D7 of stoppage of caffeine;Median day of apnoea occurrenceTimepoint: Daily till discharge or death;Proportion of neonates requiring re-initiation of respiratory supportTimepoint: Daily till discharge or death;Proportion of neonates with Bronchopulmonary dysplasia (BPD), Necrotizing enterocolitis (NEC), Patent Ductus Arteriosus (PDA), Retinopathy of Prematurity (ROP), Extra Uterine Growth Restriction (EUGR)Timepoint: Daily till discharge or death;Proportion of neonates with feed intoleranceTimepoint: Daily till discharge or death;Time to regain birth weightTimepoint: Daily till discharge or death

—

Countries

India

Contacts

Public ContactDr Santhiya S

Lady Hardinge Medical College

drsnangia@gmail.com9810838181

Outcome results

None listed

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