| CTRI Number |
CTRI/2025/11/096996 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PROCESS OF CARE CHANGES] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different levels of PEEP during delivery room resuscitation in preterm babies |
|
Scientific Title of Study
|
Comparison of two levels of positive end expiratory pressure for delivery room resuscitation in preterm neonates of less than 32 weeks’ gestation : 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 |
Dr Sattiraju Sarvani |
| Designation |
Senior Resident (Academic), DM Neonatology |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Neonatology, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9000067954 |
| Fax |
|
| Email |
sattirajusarvani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Khare |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Assistant Professor, Department of Neonatology, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9843395041 |
| Fax |
|
| Email |
drchetankhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Khare |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Assistant Professor, Department of Neonatology, AIIMS Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9843395041 |
| Fax |
|
| Email |
drchetankhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Campus road, saket nagar, habibganj,Bhopal, MP- 462020 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
AIIMS campus road, saket nagar, habibganj, BHOPAL, MP- 462020 |
| Type of Sponsor |
Government 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 Sattiraju Sarvani |
Department of Neonatology, AIIMS Bhopal |
Department of Neonatology, AIIMS Bhopal, Saket Nagar, Bhopal, MP 462020, India
Bhopal
MADHYA PRADESH |
9000067954
sattirajusarvani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee – Student Research, AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P289||Respiratory condition of newborn,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PEEP 5-6 cm of water |
PEEP 5-6 cm of water via T piece resuscitator during delivery room resuscitation till stabilisation |
| Intervention |
PEEP 7-8 cm of water |
PEEP 7-8 cm of water via T piece resuscitator during delivery room resuscitation till stabilisation. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.Inborn preterm infants less than 32 weeks gestation requiring resuscitation in delivery room. |
|
| ExclusionCriteria |
| Details |
1.Antenatally diagnosed major congenital anomalies or chromosomal disorders.
2.Infants born via MTP.
3.Hydrops fetalis or pulmonary hypoplasia.
4.Preterm new born with surgical conditions.
5.Antenatal diagnosis of conditions resulting in poor prognosis.
6.Peri viable new borns |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Incidence of endotracheal intubation within 72 hrs of birth
2.trends of oxygenation(modified oxygenation index SpO2/FiO2) in first 72 hrs of birth
3.Incidence of hypoxic respiratory failure in first 72 hrs of birth in mechanically ventilated new born |
At 2,4,6 and then 6 hourly till 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Need for surfactant replacement therapy in first 72 hrs.
2.CPAP failure rate in first 72 hrs after CPAP therapy initiation in NICU.
3.Duration of mechanical ventilation.
4.Duration of respiratory support.
5.Duration of oxygen
6.Hemodynamic compromise in the first 72hrs
7.Rates of BPD at 36 weeks PMA.
8.Incidence of airleak syndromes.
9.Preterm mortality & morbidities like IVH 3/4 , NEC ,ROP, PVL, Culture proven sepsis , duration of NICU stay.
10. Delivery room clinical parameters |
At 2,4,6 & then 6 hourly.
3days, 7 days, 14 days & 28 days or at discharge.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The current strategies of preterm lung recruitment at birth remain ineffective especially in preterms who require delivery room resuscitation. The AAP advocates a prompt creation of FRC for positive outcomes. On this principle , the use of PEEP with resuscitation devices for optimal benefits in non vigorous preterms is being practiced. Provision of PEEP has decreased burden of respiratory interventions and improved outcomes. While the range of distending pressures are wide , lower ranges are used routinely. This trial is planned to compare clinical benefits of resuscitating preterms of less than 32 weeks of gestation with recommended pressures of PEEP at lower ranges of 5-6 cm of water versus 7-8 cm of water in delivery room till stabilization. |