Respiratory distress of newborn ICD codes P22.0, P22.8, P22.9
Conditions
Interventions
Product Name: Medical Grade Oxygen
Product Code: O2
Pharmaceutical Form: Inhalation gas
CAS Number: 7782447
Other descriptive name: OXYGEN
Product Name: Medical Grade Oxygen
Product Code: O2
Pharmace
Sponsors
University of Oxford, Research Governance & Clinical Trials Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants are eligible if they are: (a) they are less than 28 weeks’ gestation at birth and (b) they are less than 12 hours old (24 hours old if the baby is outborn) and (c) the clinician and parents are substantially uncertain which SpO2 is better and (d) the parent(s) have given written informed consent to their baby’s participation Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Recruitment is not appropriate if there is no realistic prospect of survival, or follow-up is unlikely to be possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does varying the concentration of inspired oxygen so as to target a low (85–89%) versus a high (91–95%) functional arterial oxygen saturation (SpO2), from the day of birth until the baby is breathing air (or until the baby has reached a postmenstrual age of at least 36 weeks) affect the incidence of: (1) death or severe neurosensory disability on assessment 2 years after the child was due to be born (2) the length of time the baby is judged to need respiratory support (3) the severity of any retinopathy of prematurity and its two year outcome (4) the need for surgery (for conditions such as retinopathy of prematurity, patent ductus arteriosus, post-haemorrhagic ventriculomegaly and gastrointestinal problems such as necrotising enterocolitis) (5) chronic lung disease (6) poor weight gain and head growth between birth and 36 weeks postmenstrual age, and between birth and 2 years of corrected age ;Secondary Objective: ;Primary end point(s): Death or serious neurosensory disability at 2 years corrected for prematurity NB: neurodisability is defined as any of the following: • a cognitive score of <70 (i.e. more than 2 standard deviations below the mean) using the Bayley Scale of Infant Development (BSID-3); • severe visual loss (certified as legally blind or partially sighted); • severe cerebral palsy (unable to walk without help at 2 years) • deafness requiring (or too severe to benefit from) a hearing aid. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed