| CTRI Number |
CTRI/2017/10/010001 [Registered on: 04/10/2017] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the benefits of nasal breathing support in premature babies |
|
Scientific Title of Study
|
Efficacy & safety of standard Vs high flow rates of Nasal High Flow therapy in very preterm neonates- A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haribalakrishna Balasubramanian |
| Designation |
Consultant Neonatologist |
| Affiliation |
Surya Childrens Hospital |
| Address |
Department of Neonatology,
4th floor, New building
Surya children’s Hospital,
Junction of S V road and Dattatray road, SV Road
Santa Cruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9820457078 |
| Fax |
|
| Email |
doctorhbk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawandeep Garg |
| Designation |
DNB Neonatology trainee |
| Affiliation |
Surya Childrens Hospital |
| Address |
Department of Neonatology,
4th floor, New building
Surya children’s Hospital,
Junction of S V road and Dattatray road, SV Road
Santa Cruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
7738617972 |
| Fax |
|
| Email |
bhawandeepgarg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawandeep Garg |
| Designation |
DNB Neonatology trainee |
| Affiliation |
Surya Childrens Hospital |
| Address |
Department of Neonatology,
4th floor, New building
Surya children’s Hospital,
Junction of S V road and Dattatray road, SV Road
Santa Cruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
7738617972 |
| Fax |
|
| Email |
bhawandeepgarg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surya Children Hospital |
| Address |
Department of Neonatology,
4th floor, New building
Surya children’s Hospital,
Junction of S V road and Dattatray road, SV Road
Santa Cruz West, Mumbai |
| Type of Sponsor |
Other [Children hospital] |
|
|
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 Haribalakrishna Balasubramanian |
Surya Childrens hospital |
Department of Neonatology,
4th floor, New building
Surya children’s Hospital,
Junction of S V road and Dattatray road, SV Road
Santa Cruz West, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9820457078
doctorhbk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Surya Childrens medicare pvt ltd |
Approved |
| Surya Childrens medicare pvt ltd |
Approved |
| Surya Childrens medicare pvt ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, Premature neonates at birth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5-7 litres/min of standard nasal flow therapy |
5-7 litres/min of heated humidified nasal high flow thearpy initiated in preterm infants with respiratory distress within 6 hrs of birth |
| Intervention |
8-10 litres/min of nasal high flow therapy |
8-10 litres/min of heated humidified nasal high flow thearpy initiated in preterm infants with respiratory distress within 6 hrs of birth |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants more than 28 weeks of gestation and/or more than 1 kg birth weight with respiratory distress and FiO2 requirement >30% within first 6 hours of birth. |
|
| ExclusionCriteria |
| Details |
1) Birth weight <1000 grams
2) Gestational age <28 weeks
3) Infant who already received surfactant
4) Pneumothorax on Chest X-ray
5) Shock requiring inotropic support, multi organ dysfunction and encephalopathy
6) Abnormalities of upper and lower airways precluding use of HHHFNC (Pierre-Robin, Treacher Collins, Goldenhar, choanal atresia, cleft lip/palate)
7) Serious abdominal, cardiac, or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, or diaphragmatic hernia.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| HHHFNC failure rate -composite outcome defined by the need of a) CPAP support b) surfactant treatment c) mechanical ventilation |
from birth until fifth day of postnatal age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of respiratory support
2. Duration of oxygen therapy.
3. Need of CPAP
4. Need of surfactant treatment
5. Need of mechanical ventilation
6. Mortality due to any cause.
7. Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema)
8. Nasal injuries |
from admission until NICU discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2017 |
| Date of Study Completion (India) |
14/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/01/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary purpose of the study would be to compare the failure rate of standard nasal flow rate (SFR) vs high nasal flow rate (HFR) initiated within 6 hrs of age in premature infants >= 28 weeks of gestation with respiratory distress syndrome.
Eligible infants will be allocated to one of the two groups, (SFR Vs HFR) after obtaining written informed consent from the parents. With worsening respiratory distress, the nasal flow rate would be increased by 2 litres/min and would be considered for CPAP support, surfactant therapy or mechanical ventilation in that order.
|