PRETERM AFRICA STUDY

Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202502489638730

Enrollment

1512

Registered

2025-02-24

Start date

2025-01-01

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

Neonatal Diseases Respiratory Paediatrics

Interventions

Vayu Bubble CPAP and Caffeine Citrate

Vayu Bubble CPAP. Caffeine Citrate. Less Invasive Surfactant Administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks. 2. Silverman Anderson Score =5 before or after CPAP treatment. 3. Admitted to a study site within 24 hours of life. 4. Parents provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Major congenital or genetic anomalies. 2. Active pulmonary hemorrhage. 3. Major craniofacial anomalies that preclude the successful use of CPAP.

Design outcomes

Primary

Measure	Time frame
Survival	—

Secondary

Measure	Time frame
Survival at 72 hours of life ;The incidence of major complications of prematurity including retinopathy of prematurity, neonatal sepsis, intracranial hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, and pneumothorax.	—

Countries

Central African Republic, Ghana, Kenya, Nigeria

Contacts

Public ContactOlufunke ; Naana Bolaji;Wireko Brobby

Consultant Paediatrician ;Consultant neonatologist

olufunke.bolaji@gmail.com;mayiwah@yahoo.com+2347081007368;+233550348764

Outcome results

None listed

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