Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Sponsors
World Health Organization
Eligibility
Inclusion criteria
Inclusion criteria: The population of interest is women with singleton or multiple pregnancy at 34 weeks to 36 weeks and 5 days and a high probability of late preterm birth (which extends up to 36 weeks 6 days). 1. Gestational age from 34 weeks 0 days to 36 weeks 5 days 2. High probability of late preterm birth (up to 36+6 weeks) defined as birth expected between 12 hours and 7 days after randomization as a result of: A. Membrane rupture without preterm labour (where preterm labour is defined as at least 6 regular uterine contractions/ hr and any one of the following: cervical dilatation of more than or equal to 3 cm or effacement more than or equal to 75%). OR B. Preterm labour with intact membranes, defined as at least 6 regular contractions/hr and one of the following: (i) cervix more than or equal to 3cm dilated or (ii) 75% effaced; OR C . Planned delivery by induction of labour or caesarean section between 24hours and 7 days, as deemed necessary by the provider. An induction must be scheduled to start by 36+5 weeks at the latest, whereas a caesarean delivery must be scheduled by 36+6 weeks at the latest 3. Singleton or multiple pregnancies, where the foetus/es (or at least one foetus in a multiple pregnancy) is/are confirmed alive by doppler or USG 4. Women with no clinical signs of severe infection (as per obstetric care physician’s assessment) 5. Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent) Women with the following conditions will be eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations: -Women with a history of previous preterm birth -Women with hypertensive disorders -Women with a growth impaired foetus -Women with pre-gestational or gestational diabetes -Women with HIV/AIDs
Exclusion criteria
Exclusion criteria: 1. Ruptured membranes with cervix dilated more than or equal to 3cm or effaced more than or equal to 75%, or with more than 6 contractions per hour (or both) 2. Cervical dilation of more than or equal to 8 cm with intact membranes 3. Clinical suspicion or evidence of clinical chorioamnionitis or severe infection, as per obstetric care physician assessment 4. Evidence of non-reassuring foetal status requiring immediate delivery 5. Major or lethal congenital foetal anomaly identified 6. No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible 7. Any systemic corticosteroid use during the current pregnancy (outside of trial) 8. Unwilling or unable to provide consent or assent (including due to active labour) 9. Currently a participant in another clinical trial related to maternal and neonatal health, or previously participated in any ACTION trial 10. Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stillbirth (post randomization) OR neonatal death within 72 hours of birth OR use of respiratory support within 72 hours of birth or until discharge from hospital, whichever is earlier. Use of respiratory support consists of any one of the following: use of mechanical ventilation; continuous use of CPAP for 12 hours or more with an FiO2 more than or equal to 0.4 at any time; continuous use of supplementary oxygen for 24 hours or more with an FiO2 of more than or equal to 0.4 at any timeTimepoint: Stillbirth: at time of delivery Neonatal death: within 72 hours of birth 3) Use of respiratory support in neonate anytime within 72 hours of birth or until discharge from hospital whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Newborn: Efficacy outcomes: (i) Stillbirths (ii) Neonatal death within 72 hours, 7 days, 28 days of birth (iii) Resuscitation at birth i.e. use of positive pressure ventilationTimepoint: Stillbirth and resuscitation at time of delivery Neonatal death: Up to 28 days of birth;Newborn: Efficacy outcomes: (iv) Severe respiratory distress (SRD) within 72 hours after birth or until discharge from hospital, whichever is earlier. SRD is defined as any of the following clinical signs: respiratory rate more than or equal to 70/ min, chest indrawing, grunting, or SpO2 less than 90%, any of which are present at two or more consecutive 6 hourly assessments.Timepoint: Severe respiratory distress: within 72 hours after birth or until discharge from hospital, whichever is earlier;Newborn: Efficacy outcomes: (v) Use of respiratory support i.e. any one of the following: mechanical ventilation; continuous use of CPAP for 12 hours or more with an FiO2 more than or equal to 0.4 at any time; continuous use of supplementary oxygen for 24 hours or more with an FiO2 more than or equal to 0.4 at any time Timepoint: Use of respiratory support: within 72 hours of birth or until hospital discharge whichever is earlier;Newborn: Efficacy outcomes: (vi) Still birth OR neonatal death in 72h OR mechanical ventilation OR need for very high CPAP settings (more than or equal to 8 cm water pressure and more than or equal to 0.7 FiO2) in 72h after birth (vii)Cause specific mortalityTimepoint: Stillbirth: at time of delivery Neonatal death, mechanical ventilation: within 72 hours of birth;Newborn Safety outcomes: (i) Clinically suspected neonatal sepsis (less than or equal to 7days) (ii) Neonatal hypoglycaemia (blood glucose 45 mg% at 2, 6, 12, 24 or 36 h, or detected anytime 36 h based on a test because of clinical suspicion)Timepoint: Neonatal sepsis: within 7days of birth Neonatal hypoglycemia: within 36 of birth;Newborn Health service utilization outcomes: (i) Admission to neonatal c | — |
Countries
Bangladesh, India, Kenya, Nigeria, Pakistan
Contacts
Public ContactDr Shivaprasad S Goudar
Vardhaman Mahavir Medical College and Safdarjung Hospital
Outcome results
None listed