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Effect Of N-Acetylcysteine On Outcomes Of Perinatal Asphyxia; A Multicentre, Double-Blind Randomised Control Trial

Effect Of N-Acetylcysteine On Outcomes Of Perinatal Asphyxia; A Multicentre, Double-Blind Randomised Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202409657658949
Enrollment
81
Registered
2024-09-03
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Paediatrics

Interventions

Normal Saline
Healthy Control Cohort

Sponsors

Babcock University
Lead Sponsor
Babcock University Teaching Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Asphyxiated inborn late preterm and term babies in the participating hospitals. Diagnosis of PA defined satisfying at least two of the following parameters: (i) 5-minute APGAR score 10.0 mmol/L. b. Term neonates = 37 – 42 weeks EGA c. Birth weight = 2500g

Exclusion criteria

Exclusion criteria: a. A neonate whose mother has chorioamnionitis (defined as maternal fever =38°C in the presence of rupture of membranes or 2 clinical findings: uterine tenderness, maternal white blood cell >15,000 cells/mm, foetal tachycardia >160 bpm, or malodorous amniotic fluid). b. Evidence TORCH infections in the mother c. Use of antioxidants, high dose Vitamin C/E, or chronic corticosteroids by the mother in the peripartum period d. A neonate with family history of bleeding disorder e. A neonate whose cord blood demonstrates Glucose 6-phosphate dehydrogenase deficiency f. A neonate whose prothrombin time is prolonged. g. A neonate whose mean BP is < 40 mmHg. h. Presence of major congenital malformations, chromosomal abnormalities (e.g., Trisomy 21), or dysmorphic features suggestive of a genetic syndrome i. Meconium aspiration syndrome

Design outcomes

Primary

MeasureTime frame
Survival and the duration to recovery based on daily monitoring with the Thompson Score is the primary outcome.;Survival and the duration to recovery based on daily monitoring with the Thompson Score is the primary outcome.—

Secondary

MeasureTime frame
Neuroimaging findings;Neuroimaging findings—

Countries

Nigeria

Contacts

Public ContactVictor;Victor Ayeni;Ayeni

Senior Lecturer and Consultant Neonatologist at Babcock University and Babcock University Teaching Hospital Ilishan Remo;Senior Lecturer and Consultant Neonatologist at Babcock University and Babcock University Teaching Hospital Ilishan Remo

tioluwa@hotmail.com;tioluwa@hotmail.com+2348059324867;+2348059324867

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026