Health Condition 1: P00-P96- Certain conditions originating in the perinatal period
Conditions
Interventions
Intervention1: Intact Cord resuscitation: a. If the neonate doesnâ??t cry immediately, then the neonate would be resuscitated on the indigenous prototype trolley manufactured by Phoenix® which could
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: Late Preterm and term neonates (>=34 0/7 weeks of gestation onwards) at risk for resuscitation. These will include pregnancies with the following complications 1. Fetal heart rate (HR) tracing showing Category II or III CTG findings as per ACOG guidelines or Pathological or Suspicious as per NICE guidelines. Category I, which is suggestive of a normal CTG, will not be included. 2. Pathological or Suspicious CTG as per NICE 2014 guidelines 3. Shoulder dystocia, Fetal macrosomia 4. Fetal malpresentation ( breech, shoulder, face and brow presentation, sinciput presentation and asynclitism) and malposition (occipito-posterior and occipito-transverse) 5. Obstructed Labour 6. Vacuum- or forceps-assisted vaginal delivery 7. Meconium-stained amniotic fluid 8. Chronic hypertension and Preeclampsia or eclampsia 9. Twin (diamniotic diachronic twins) In this case, only the second foetus will be randomised for the study. The first twin will not be part of the study and will receive the standard of care. 10. Polyhydramnios/oligohydramnios 11. Fetal Growth Restriction 12. Chorioamnionitis 13. Intra-partum Bleeding 14. Severe Maternal Anemia at the time of delivery
Exclusion criteria
Exclusion criteria: 1. Antenatally detected life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation) 2. Suspected severe fetal anemia 3. Mono-chorionic or mono-amniotic twins 4. Three or greater order in multiple gestation 5. Decision made for comfort care only 6. Complete placental abruption, Placenta Previa 7. Bad Obstetric History (Recurrent Pregnancy Loss) as per RCOG definition 8. Use of Assisted Reproductive Technology like In Vitro Fertilization 9. Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-ductal SaO2 in first 10 minutes of life with SaO2 at first 10 minutes of lifeTimepoint: Pre-ductal SaO2 in first 10 minutes of life with SaO2 at first 10 minutes of life | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time to reach 90% pre-ductal SaO2 (seconds)Timepoint: seconds;10) Temperature at 15, and 30 minutes of life.Timepoint: 15, and 30 minutes of life.;11) Need for positive pressure ventilationTimepoint: upto 5 min of life;12) Duration of positive pressure ventilationTimepoint: seconds of PPV;13) Need for supplemental O2Timepoint: During resuscitation;14) Duration of supplemental O2Timepoint: During resuscitation;15) Need for chest compressionsTimepoint: During resuscitation;16) Duration of chest compressionsTimepoint: During resuscitation;17) Need for intubationTimepoint: During resuscitation;18) Period remained intubatedTimepoint: During resuscitation;19) Grading of Hypoxic Ischemic Encephalopathy using Sarnat and Sarnat staging.Timepoint: Within 6 hours of life;2) SaO2 at 1 and 5 min of life (percentage)Timepoint: 1, 5 min of life;20) Need for Therapeutic HypothermiaTimepoint: Within 6 hours of life;21) Thompson Score at baseline, at 6, 12 hours of life, then Q12H until therapeutic hypothermia (TH) is complete.Timepoint: 6, 12 hours of life, then Q12H until therapeutic hypothermia;22) Maximum Thompson score during in subset of neonates developing hypoxic-ischemic encephalopathyTimepoint: During NICU/ hospital stay;23) Incidence of seizures related to HIETimepoint: During NICU/ hospital stay;24) Hematocrit at 12±3, 24±3 and 48±3 hours of lifeTimepoint: 12±3, 24±3 and 48±3 hours of life;25) Transcutaneous bilirubin(TcB) at 24±3, 48±3 , 72±3 hours of life and at dischargeTimepoint: 24±3, 48±3 , 72±3 hours of life and at discharge;26) Need for phototherapy for hyperbilirubinemiaTimepoint: During NICU/ hospital stay;27) Cranial Ultrasound findings- (Objective criteria to be mentioned)Timepoint: During NICU/ hospital stay;28) MRI done between 3 to 10 days of lifeTimepoint: 3 to 10 days of life;29) Incidence of ShockTimepoint: During NICU/ hospital stay;3) Expanded Apgar score at 1, 5 min (10 min, if applicable ) of lifeTimepoint: 1, 5 min ,10 min, of li | — |
Countries
India
Contacts
Public ContactDR NEERAJ GUPTA
DEPARTMENT OF NEONATOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, (AIIMS),
Outcome results
None listed