| CTRI Number |
CTRI/2025/02/080833 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Early Caffeine Discontinuation at 32 Weeks in Preterm Babies: Evaluating Apnea Recurrence at 32 vs. 34 Weeks – The SAFE-CAFE Study" |
|
Scientific Title of Study
|
Safety Assessment for Early Caffeine Weaning: SAFE-CAFE PILOT Randomised Controlled Trial |
| Trial Acronym |
SAFE - CAFE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek S Gowdar |
| Designation |
Senior resident, DM Neonatology |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Neonatology, A Block, First Floor, AIIMS Raipur, Tatibandh, Raipur, 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
7838170739 |
| Fax |
|
| Email |
abhisheksg.4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Phalguni Padhi |
| Designation |
Associate Professor and Incharge |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Neonatology, 1st floor, A Block, AIIMS Raipur, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
9040632169 |
| Fax |
|
| Email |
phalguni2011@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhishek S Gowdar |
| Designation |
Senior resident, DM Neonatology |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Neonatology, A Block, First Floor, AIIMS Raipur, Tatibandh, Raipur, 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
7838170739 |
| Fax |
|
| Email |
abhisheksg.4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
Gate No 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Phalguni Padhi |
Associate Professor and In-Charge, Department of Neonatology, AIIMS Raipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Phalguni Padhi |
NICU, AIIMS RAIPUR |
NICU, 1st floor, A Block, Department of Neonatology, AIIMS Raipur Raipur CHHATTISGARH |
9040632169
phalguni2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P284||Other apnea of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional discontinuation of Group
|
Caffeine citrate will be stopped at 34 weeks of PMA |
| Intervention |
Early discontinuation of caffeine citrate Group
|
Caffeine citrate will be stopped at 32 weeks of PMA. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with a gestational age ranging from 26 to 31+6 weeks admitted in NICU and started on caffeine citrate (1. For treatment of apnea of prematurity, 2.All neonates admitted with respiratory distress requiring CPAP support) |
|
| ExclusionCriteria |
| Details |
1.Major congenital anomalies
2.Grade III and grade IV Intraventricular hemorrhage
3.Drugs that can cause CNS depression - Antiepileptics, Morphine, Midazolam
4.Babies born with Birth Asphyxia
5.Baby on respiratory support higher than HFNC of 3L flow and 25% FiO2
6.Receiving treatment for Sepsis / PDA at the time of randomisation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Infants with recurrence of Clinically Significant Apnea from Randomization till discharge in each of the two groups |
Discharge of baby from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gestation-specific day of recurrence of apnea post-caffeine discontinuation. |
Discharge of baby from hospital |
| Recurrence risk in subgroups based on gestational age at birth and severity of respiratory illness. |
discharge of baby from hospital |
| To assess the relationship between apnea recurrence after caffeine cessation and the number of days off CPAP before recurrence. |
Discharge of baby from hospital |
| Compare incidence of BPD in the two groups |
Discharge from hospital |
| Occurrence of extrauterine growth restriction in the two groups. |
Discharge of baby from hospital |
| Risk of retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and abnormal cranial ultrasound findings. |
Till 3 months corrected ago follow up |
| Cost-effectiveness analysis for early discontinuation. |
Discharge from hospital |
| Neurodevelopmental outcome at 3 months post-caffeine discontinuation. |
Till 3 months corrected age follow up |
|
|
Target Sample Size
|
Total Sample Size="186" Sample Size from India="186"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2025 |
| Date of Study Completion (India) |
10/02/2026 |
| Date of First Enrollment (Global) |
28/02/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Apnea of prematurity (AOP) is a common developmental disorder affecting preterm infants due to their immature respiratory control.It is characterised by episodes of breathing cessation lasting 20 seconds or longer often accompanied by bradycardia, cyanosis or pallor. The prevalence of AOP decreases as gestational age increases with higher incidence in infants born <28 weeks gestation. Caffeine has emerged as preferred pharmacological treatment for AOP and is widely used in neonatal intensive care units. It has shown to reduce the duration of mechanical ventilation, lower risk of bronchopulmonary dysplasia, and improve neurodevelopment outcomes. Despite its efficacy, there is lack of consensus regarding optimal duration of caffeine therapy. Clinical practises vary regarding when to discontinue caffeine therapy. Some units advocate for extended use until infants reach 34-35 weeks post menstrual age (PMA) or beyond, while others opt for early discontinuation after seven consecutive apnea-free days. The decision to stop caffeine is often based on decreasing risk of AOP as PMA increases. Extending caffeine therapy may reduce the risk of apnea recurrence however, prolonged use comes with challenges such as tachycardia, feed intolerance, and reduced weight gain. Additionally, keeping infants on caffeine until a certain PMA threshold may prolong hospital stays and increase care costs. Conversely, a shorter course of caffeine therapy may heighten the risk of apnea recurrence, necessitating a balance between the benefits and potential drawbacks of continued caffeine use. Existing literature on duration of caffeine therapy and its impact on AOP recurrences limited, with few controlled trials addressing this issue. Our study aims to address this gap by comparing the recurrence of AOP between two groups : Group 1, where caffeine is discontinued at 32 weeks PMA, and group 2 where caffeine is continued till fixed period of 34 week sand stopped. This research will contribute to a better understanding of optimal caffeine management in preterm infants and guide clinical decision making regarding AOP treatment duration. |