Health Condition 1: null- Neonates/ Premature Babies
Conditions
Interventions
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.
Sponsors
The University of Sydney represented by and acting through the NHMRC Clinical Trials Centre
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare survival without major disability at 2 years corrected for gestation age.Timepoint: 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia, India, Malaysia, New Zealand, United States of America
Contacts
Public ContactDr R Kishore Kumar
Kids Clinic India Pvt. Ltd.
Outcome results
None listed