| CTRI Number |
CTRI/2015/08/006067 [Registered on: 03/08/2015] Trial Registered Prospectively |
| Last Modified On: |
14/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Arterial carbon dioxide level after brief ventilation using self inflating bag versus T- piece resuscitator following surfactant therapy |
|
Scientific Title of Study
|
To compare the arterial PCO2 level after brief ventilation using self inflating bag versus T- piece resuscitator post surfactant instillation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandkishor S Kabra |
| Designation |
Neonatologist |
| Affiliation |
Surya Childrens Hospital |
| Address |
Surya childrens Hospital, Junction of S V road and Dattatraya road, Santacruz West,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9820919271 |
| Fax |
912261538990 |
| Email |
nskabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrit Jeevan |
| Designation |
Senior Resident |
| Affiliation |
Surya Childrens Hospital |
| Address |
Surya childrens Hospital, Junction of S V road and Dattatraya road, Santacruz West,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9930095491 |
| Fax |
912261538990 |
| Email |
dramritjeevan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrit Jeevan |
| Designation |
Senior Resident |
| Affiliation |
Surya Childrens Hospital |
| Address |
Surya childrens Hospital, Junction of S V road and Dattatraya road, Santacruz West,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9930095491 |
| Fax |
912261538990 |
| Email |
dramritjeevan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surya Children Hospital |
| Address |
Surya childrens Hospital, Junction of S V road and Dattatraya road, Santacruz West,Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amrit Jeevan |
Surya childrens Hospital, Junction of S V road and Dattatraya road, Santacruz West,Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandkishor S Kabra |
Surya Childrens Hospital |
Surya Childrens Hospital, junction of S V Road and Dattatraya Road, Santacruz West
Mumbai (Suburban)
MAHARASHTRA |
9820919271
912261538990
nskabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Childrens Hospital Academic Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm infants with respiratory distress syndrome and FiO2 requirement of 30% needing first dose of surfactant admitted to Surya Children’s Hospital NICU, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self inflating bag (SIB) |
Self inflating bag (SIB) will be used for intermittent positive pressure ventilation during surfactant administration |
| Intervention |
T -piece resuscitator(TPR) |
T- piece resuscitator (TPR) will be used for intermittent positive pressure ventilation during surfactant administration |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
preterm infants with respiratory distress requiring 1st dose of surfactant |
|
| ExclusionCriteria |
| Details |
Antenatally diagnosed congenital heart disease such as complex cyanotic heart disease
Infants who have received first dose of surfactant prior to transfer to the hospital
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in arterial CO2 pre and post surfactant administration in SIB (Self inflating bag) versus TPR (T-Piece Resuscitator) group
|
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean PaCO2 six hours post surfactant administration (mm Hg) |
6 hours |
| Mean PaO2 six hours post surfactant administration (mm Hg) |
6 hours |
| Requirement of assisted ventilation (%) |
1st week of life |
| Type of respiratory support required (%) |
1st week of life |
| Duration of respiratory support (days) |
28 days |
| Duration of oxygen therapy (days) |
28 days |
| Duration of hospital stay (days) |
at the time of discharge from NICU |
| Incidence of air leak/Pneumothorax (%) |
28 days |
| Incidence of Intraventricular Hemorrhage -IVH and Periventricular leucomalacia PVL (%) |
28 days |
| Incidence of Retinopathy of prematurity ROP (%) |
at the time of discharge from NICU |
| Incidence of Necrotising Enterocolitis -NEC (%) |
28 days |
| Incidence of Bronchopulmonary Dysplasia BPD (%) |
at 36 weeks of post conceptional age |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2015 |
| Date of Study Completion (India) |
30/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Jeevan A, Balasubramanian H, Kabra N. Effect of T-Piece Resuscitator versus Self Inflating Bag on Arterial CO2 Levels in Preterm Neonates. Indian J Pediatr. 2020 Nov;87(11):897-904. doi: 10.1007/s12098-020-03393-x. Epub 2020 Jul 14. PMID: 32666238; PMCID: PMC7358992. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
AIM: To evaluate the effect of manual ventilation with T piece resuscitator or self-inflating bag during surfactant administration by measuring the mean change in arterial carbon dioxide levels following administration. METHODS: Preterm neonates requiring first dose of surfactant within 24 hours of life were randomized to receive positive pressure ventilation with either self inflating bag or T piece resuscitator during surfactant administration. Arterial blood gases were obtained at baseline and one hour after the surfactant dose. Primary outcome was change in PaCO 2 levels one hour after the intervention estimated as difference between baseline and PaCO 2 levels after brief manual ventilation. RESULTS: A total of 80 neonates were enrolled in the study (40 in each group). The drop in PaCO 2 at one hour was significantly higher in the group ventilated with the self inflating bag as compared to the T-piece resuscitator group (10.01 mmHg Vs 0.89 mmHg, Mean difference=9.13 mmHg, [95% confidence interval: 5.03-13.22; P <; 0.001]). This difference was also significant at six hours after the intervention. The PaCO 2 change was also evident in the subgroup of infants that required only non invasive ventilation (10.8 mmHg Vs 0.75 mmHg,Mean difference= 10.04, [95% confidence interval: 5.35-14.74; P< 0.001]). The need for seconddose of surfactant was lower in the T piece group (55% Vs 77%, P=0.03) CONCLUSIONS: Use of T-piece resuscitator results in lesser reduction in PaCO 2 levels compared tothe self inflating bag, when used for brief manual ventilation during surfactant administration. Keywords: T – Piece Resuscitator, Self – Inflating Bag, Surfactant
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