N-acetylcysteine to improve neurological outcomes in neonates with hypoxic ischemic encephalopathy

N-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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031798

Enrollment

122

Registered

2021-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified

Interventions

Intervention1: N-acetylcysteine: Individual boxes containing the study drug will be prepared by a person who is not involved in the care of the infant. Both N-acetyl cysteine and normal saline (compar

Eligibility

Inclusion 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 = 12 meq/L 2. Any one of the below mentioned criteria i. APGAR 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: 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

Design outcomes

Primary

Measure	Time frame
Composite outcome of death or abnormal neurodevelopment at 6 months of age.Timepoint: Six months corrected age	—

Secondary

Measure	Time frame
A. Serum levels of oxidative stress markers (malondialdehyde and total antioxidant status) at baseline and on day 6 after completion of the study drugTimepoint: Day 1, day 6;Death in the first 6 months of lifeTimepoint: 6 months of life;In-hospital morbidity a. Seizures requiring more than one anticonvulsant b. Discharge home on anticonvulsant therapy c. Duration of inotrope therapy d. Days on invasive mechanical ventilation e. Time to reach full oral feeds f. Coagulopathy or bleeding requiring FFP transfusion g. Thrombocytopenia (platelets 1,00,000) h. Abnormal neurological examination at discharge i. Electrolyte abnormalitiesTimepoint: during hospital stay;Major neurodevelopmental disability at 6 months of age a. Developmental assessment scales for Indian Infants (DASII) score 70 b. Epilepsy at 6 months of age c. No visual fixation or following d. Hearing deficit requiring aidsTimepoint: six months age;Neonatal mortalityTimepoint: 28 days of life	—

Measure

Time frame

A. Serum levels of oxidative stress markers (malondialdehyde and total antioxidant status) at baseline and on day 6 after completion of the study drugTimepoint: Day 1, day 6;Death in the first 6 months of lifeTimepoint: 6 months of life;In-hospital morbidity a. Seizures requiring more than one anticonvulsant b. Discharge home on anticonvulsant therapy c. Duration of inotrope therapy d. Days on invasive mechanical ventilation e. Time to reach full oral feeds f. Coagulopathy or bleeding requiring FFP transfusion g. Thrombocytopenia (platelets 1,00,000) h. Abnormal neurological examination at discharge i. Electrolyte abnormalitiesTimepoint: during hospital stay;Major neurodevelopmental disability at 6 months of age a. Developmental assessment scales for Indian Infants (DASII) score 70 b. Epilepsy at 6 months of age c. No visual fixation or following d. Hearing deficit requiring aidsTimepoint: six months age;Neonatal mortalityTimepoint: 28 days of life

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Countries

India

Contacts

Public ContactNishad Plakkal

JIPMER

plakkal@gmail.com7708577133

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026