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Clinical Trials/CTRI/2021/03/031798
CTRI/2021/03/031798
Not yet recruiting
Phase 4

acetylcysteine as an adjunct to therapeutic hypothermia in the management of term or late preterm neonates with hypoxic ischemic encephalopathy to prevent the composite outcome of death or major neurodevelopment disability at 6 months postnatal age: a randomized, double-blind, placebo- controlled trial - HypNAC

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
Sponsor
Jawaharlal Institute of Postgraduate Medical Education and Research
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria (The baby should meet criteria from either A or B, plus the criteria in C)
  • 1\. Inborn babies with gestational age \>\= 36 weeks with ABG (umbilical cord or 1st postnatal hour) pH \<\=7 or Base deficit \>\= 12 meq/L
  • 2\. Any one of the below mentioned criteria
  • i. APGAR \<\=5 at 10 min
  • ii. Assisted ventilation for at least 10 min after birth
  • iii. History of acute perinatal event\- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
  • 3\. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat staging).

Exclusion Criteria

  • Exclusion criteria
  • 1\) Infants \>6 hours of age at the time of randomization.
  • 2\) Major congenital abnormalities.
  • 3\) Babies who do not have spontaneous respiration at 20 minutes of life

Outcomes

Primary Outcomes

Not specified

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