To find out the required level of Oxygen for respiratory care of premature babies at the time of delivery and to check its effect on babys development.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008517
• Date of registration: 09-05-2017
• Prospective Registration: Yes
• Primary sponsor: The University of Sydney represented by and acting through the NHMRC Clinical Trials Centre
• Public title: To find out the required level of Oxygen for respiratory care of premature babies at the time of delivery and to check its effect on babys development.
• Scientific title: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome Study - TORPIDO2
• Date of first enrolment: 01-06-2017
• Target sample size: 1200
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17993
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Australia, India, Malaysia, New Zealand, United States of America

Contacts

• Name: Dr R Kishore Kumar
• Affiliation: Kids Clinic India Pvt. Ltd.

• Name: Dr R Kishore Kumar
• Affiliation: Kids Clinic India Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1)Premature infants from 23+0 weeks to 28+6 weeks Gestational Age.

2)Signed written informed consent by parents(s) or legal guardian(s)


Exclusion criteria: 1)Any known major cardio pulmonary abnormalities that could affect oxygenation or co-genital malformitions that could affect neurodevelopmental outcomes.

2) Anticipated inability to follow up for two years, e.g. Parents normally resident overseas in an inaccessible location.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Neonates/ Premature Babies

Intervention(s)

Intervention1: process of care (oxygen): not a drug related intervention. It is a process of care.
Control Intervention1: NIL: it is not applicable, as it is a non-drug related trial.

Primary Outcome(s)

To compare survival without major disability at 2 years corrected for gestation age.Timepoint: 2 years.

Secondary Outcome(s)

All-cause mortality,Survival without broncho-pulmonary dysplasia,Survival without severe retinopathy of prematurity

1. Necrotising enterocolitis receiving surgery or associated with death

2. Late onset sepsis (48 hours after birth)

3. Patent ductus arteriosus requiring treatment

4. Duration of hospital stay

5. Weight and head circumference at 36 weeks

6. Respiratory morbidity and complications

7. Spontaneous intestinal perforations

8. Brain injuryTimepoint: During NICU stay.

Secondary ID(s)

12615000115538

Source(s) of Monetary Support

National Health and Medical Research Council-Australia.

Ethics review

Status: Approved
Approval date: 19/10/2016
Contact:

Institutional Ethics Committee