CTRI/2020/10/028776
Not yet recruiting
Phase 3
Resuscitation of At Risk Term and Late Pre-term Neonates with Intact Cord vs Early Cord Clamping: A Randomized Controlled Trial - RANI
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Resuscitating newborn infants with the umbilical cord intact- The Baby-Directed Umbilical Cord Cutting (Baby-DUCC) Trialeonatal transitionNeonatal resuscitationBirth asphyxiaUmbilical cord clampingNeonatal transitionReproductive Health and Childbirth - Childbirth and postnatal careReproductive Health and Childbirth - Complications of newbornACTRN12618000621213The Royal Women's Hospital123
Recruiting
Phase 3
Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.respiratory tract infections and wheezing1004743810024970NL-OMON55914Franciscus Gasthuis & Vlietland500
Completed
Not Applicable
PEEP resuscitation in preterm neonates, a double blinded, randomized, controlled trial comparing 5cmH2O and 8cmH2O PEEP.care for neonateslung expandure1002892010028971NL-OMON35483Medisch Universitair Ziekenhuis Maastricht240
Recruiting
Not Applicable
A pilot study of patients in cardiac arrest utilising a heart-lung bypass machine prior to transport to hospital to improve survival rates.ACTRN12619000303145Ambulance Victoria25
Not yet recruiting
Not Applicable
A study to capture the patient characteristics, practices of treatment and observation measures used to maintain the blood pressure in patient presenting with early infection and low blood pressure.CTRI/2019/10/021726Indian Society of Critical Care Medicine