Finding Solutions to Thrive After Birth Asphyxia in Africa

NCT ID: NCT05275725

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-01-31

Brief Summary

Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. In low-income countries (LICs), families often lack the resources to care for affected children. For those with disabilities, stigma is high, and social and emotional impacts are substantial. Improving our understanding of NE in LICs is crucial if intervention strategies are developed. Providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential.

The primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with NE in Uganda.

Conditions

Birth Asphyxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sildenafil

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

Dose group 1st dose 2nd dose 3rd dose 4-14th doses Treatment Total dose/day frequency dose/day Group 1: #1-14=2 mg/kg q12h (4 mg/kg/day) Group 2: #1 = 2 mg/kg, #2-14 = 2.5 mg/kg q12h (5 mg/kg/day) Group 3: #1 = 2 mg/kg, #2 = 2.5 mg/kg, #3-14 = 3 mg/kg q12h (6 mg/kg/day) Group 4: #1 = 2.5 mg/kg, #2-14 = 3 mg/kg q12h (6 mg/kg/day) Group 5: #1-14 = 3 mg/kg q12h (6 mg/kg/day)

Interventions

Sildenafil

Dose group 1st dose 2nd dose 3rd dose 4-14th doses Treatment Total dose/day frequency dose/day Group 1: #1-14=2 mg/kg q12h (4 mg/kg/day) Group 2: #1 = 2 mg/kg, #2-14 = 2.5 mg/kg q12h (5 mg/kg/day) Group 3: #1 = 2 mg/kg, #2 = 2.5 mg/kg, #3-14 = 3 mg/kg q12h (6 mg/kg/day) Group 4: #1 = 2.5 mg/kg, #2-14 = 3 mg/kg q12h (6 mg/kg/day) Group 5: #1-14 = 3 mg/kg q12h (6 mg/kg/day)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female neonates meeting the criteria for birth asphyxia
• Gestational age ≥ 36 weeks and birth weight ≥ 1800 g;
• Admitted to Kawempe Hospital or Nsambya Hospital within 48 hours of life;
• Need for continued resuscitation after birth and/or 5-minute Apgar score ≤5;
• Evidence of neonatal encephalopathy by an abnormal neurological exam (modified Sarnat score of 2-3 or abnormal aEEG).

Exclusion Criteria

• Absent heart rate at 10 minutes/imminent death
• Neonates with major congenital malformations
• Neonates with grade 3 AKI (serum creatinine rise ≥3x lowest previous creatinine or creatinine > 2.5 mg/dL = 221 mcmol/L or receipt of dialysis)
• Neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cUS) performed on day 1-2 of life
• Mother living permanently outside 20km radius of Kawempe Hospital or Nsambya Hospital
• Neonates whose parents are unwilling or unable to give informed written consent to enter the study

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kawempe National Referral Hospital

UNKNOWN

Sponsor Role: collaborator

Saint Francis Hospital

OTHER

Sponsor Role: collaborator

Walimu

OTHER

Sponsor Role: collaborator

Pia Wintermark

OTHER

Sponsor Role: lead

Responsible Party

Pia Wintermark

Associate Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kawempe National Referral Hospital

Kawempe, , Uganda

Countries

Uganda

Other Identifiers

SANE-Uganda

Identifier Type: -

Identifier Source: org_study_id