Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE] Health Condition 2: P039- Newborn affected by complication of labor and delivery, unspecified Health Condition 3: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Initiating resuscitation with 90% initial FiO2 by T-piece: Resuscitation with 90% initial FiO2 by T-piece till a reliable recording of preductal pulse oxygen saturation is available fol
Sponsors
Venkataseshan Sundaram
Eligibility
Inclusion criteria
Inclusion criteria: Consecutively born preterm neonates of less than 32 completed weeks of gestation and requiring delivery room (DR) resuscitation with positive pressure ventilation (PPV) as per the most recent neonatal resuscitation program (NRP) guidelines will be included.
Exclusion criteria
Exclusion criteria: Pregnant women with insufficient time during the antenatal period to administer and obtain an informed consent Antenatally suspected or proven major structural anomalies (those responsible for death, morbidities and disability related to congenital anomalies - as per CDC definition) Parental request or neonatologist decision to forego resuscitation Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of all-cause mortality or bronchopulmonary dysplasia with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier.Timepoint: Death or 44 weeks post-menstrual age, whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| A composite of all-cause mortality or bronchopulmonary dysplasia or retinopathy of prematurity requiring treatment or necrotising enterocolitis (definite or advanced stages) or brain injury (major intra-ventricular hemorrhage or periventricular leukomalacia) with the end point of assessment being death or 44 weeks post-menstrual age, whichever is earlier.Timepoint: Death or 44 weeks post-menstrual age, whichever is earlier.;Structural changes in brain as assessed by MRI brain.Timepoint: 44 weeks PMA (term equivalent age). | — |
Countries
India
Contacts
Public ContactVenkataseshan Sundaram
Post Graduate Institute of Medical Education and Research
Outcome results
None listed