| CTRI Number |
CTRI/2024/03/064781 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early versus Conventional discontinuation of Caffeine therapy for premature babies with apnea |
|
Scientific Title of Study
|
Early versus Conventional discontinuation of Caffeine therapy for Apnea of Prematurity- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirupa Chandorkar |
| Designation |
DM Neonatology Resident |
| Affiliation |
National Institute of Medical Science and Research, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology
Near Neonatal Intensive Care Unit,
NIMS Hospital, Jaipur
Jaipur RAJASTHAN 303121 India |
| Phone |
7607817322 |
| Fax |
|
| Email |
nirupa005@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gunjana Kumar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Medical Science and Research, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology
Near Neonatal Intensive Care Unit
NIMS Hospital, Jaipur
Jaipur RAJASTHAN 303121 India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gunjana Kumar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Medical Science and Research, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology
Near Neonatal Intensive Care Unit
NIMS Hospital, Jaipur
Jaipur RAJASTHAN 303121 India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Medical Science and Research, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Medical Science and Research Jaipur Rajasthan |
| Address |
1st floor, Department of Neonatology
Near Neonatal Intensive Care Unit
NIMS Hospital, Jaipur, Rajasthan |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nirupa Chandorkar |
National Institute of Medical Science and Research, Jaipur, Rajasthan |
1st floor, Department of Neonatology
Near Neonatal Intensive Care Unit
NIMS Hospital, Jaipur, Rajasthan Jaipur RAJASTHAN |
7607817322
nirupa005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIMS University Rajasthan, Jaipur |
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 |
Caffeine therapy in all preterm neonates for apnea of prematurity will be stopped after they are apnea free and off respiratory support for 5 days and has attained the Post-Menstrual Age (PMA) of 34 weeks |
| Intervention |
Early |
Caffeine therapy in all preterm neonates for apnea of prematurity will be stopped after they are apnea free and off respiratory support for 5 days and has attained the Post-Menstrual Age (PMA) of 33 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
49.00 Day(s) |
| Gender |
Both |
| Details |
All preterm infants (both inborn and outborn) with gestational age 26 to 32 weeks and on caffeine therapy for apnea of prematurity fulfilling all the criteria below
a)Neonate with birth weight ≤1250gm or ≤ 30 weeks gestational age or Neonate with 30-32weeks gestational age and on Respiratory support receiving caffeine
b)Babies whose parents have given informed consent
|
|
| ExclusionCriteria |
| Details |
Any one of the following
a)Expired before eligibility
b)Those with major congenital anomalies (antenatally diagnosed or visible at birth)
c)Grade III or IV intraventricular haemorrhage
d)Newborn who has not been weaned off respiratory support till 32+2weeks of Post Menstrual Age (PMA)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of neonates with the recurrence of apnea after stopping caffeine therapy in both groups will be compared |
Death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following clinical outcomes will be compared in both the groups after stoppage of caffeine therapy:
1. Median day of occurrence of apnea after stopping caffeine
2. Post menstrual age at the last dose of caffeine
3. Duration of caffeine therapy
4. Proportion of neonates with feed intolerance
5. Time to regain birth weight
6. Proportion of neonates requiring re-initiation of respiratory support
7. Proportion of neonates with neonatal morbidities including BPD, NEC, PDA and ROP
8. All cause mortality
9. Duration of hospital stay
10. Adverse effect requiring reduction of caffeine dose |
Death or discharge |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 comorbidity of preterm neonates with its incidence increasing with decreasing gestation. Apnea is defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by bradycardia (<100 beats per minute), cyanosis, or pallor. On the basis of respiratory effort and airflow, apnea may be classified as central (cessation of breathing effort), obstructive (airflow obstruction usually at the pharyngeal level), or mixed. The majority of apneic episodes in preterm infants are mixed events, in which obstructed airflow results in a central apneic pause, or vice versa. The commonly used interventions to decrease the frequency and duration of apnea are continuous positive airway pressure and methylxanthine therapy. The indications for starting caffeine in preterm neonates include treatment of apnea, prophylaxis for apnea and peri-extubation. The use of caffeine is associated with certain adverse effects such as tachycardia, emesis, jitteriness, increased oxygen consumption, energy expenditure and reduced weight gain. Although there is substantial evidence for initiation of caffeine therapy, there is no standard protocol for discontinuation of caffeine therapy and studies are sparse to address this issue. As a general recommendation, most of the neonatal unit continue caffeine till 33 to 34 weeks of gestation when the risk of apnea is low, whereas others stop early, as soon as infants attain a 7-day apnea-free period. The indication and evidence for starting caffeine therapy in preterm neonates is well defined in the literature, however, the time for cessation of caffeine therapy has been consensus-based on the clinician’s decision. We planned a study to compare the occurrence of apnea in neonates where caffeine will be stopped once the neonate is apnea free and off respiratory support for 5 days and attains the post-menstrual age (PMA) of 33 weeks, with neonates where caffeine will be stopped at 34 weeks of gestation.
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