Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory F… (NCT04938167) | Clinical Trial Compass
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Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension
United States54 participantsStarted 2021-08-01
Plain-language summary
The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.
Who can participate
Age range0 Days – 28 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Corrected gestational age (postmenstrual age) \> 34 6/7 weeks
* postnatal age ≤ 28 d
* on respiratory support with invasive mechanical ventilation, non-invasive ventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with a humidifier), inspired oxygen concentration, FiO2 ≥ 0.3
* and echocardiography shows any finding suggestive of PH (or score \> 0 for PH in table 2).
* Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic encephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA), patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect (VSD) (single or multiple) \< 2 mm can be included in the study.
Exclusion Criteria:
* \< 32 weeks gestation at birth (31 6/7 or lower)
* Weight \< 2000 g at the time of enrollment
* Severe HRF with OI \> 35 or SpO2 \< 75% on FiO2 = 1.0 on mechanical ventilation for \> 60 minutes in spite of correction of reversible factors such as pneumothorax
* A condition or congenital anomaly known to be lethal (high likelihood of death during infancy) - e.g., trisomy 18 or trisomy 13
* Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) \< 2 mm.
What they're measuring
1
Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score
Timeframe: At enrollment
2
Correlation of the Oxygenation and Echocardiography components of the HRF/PH scores