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Caffeine for Apnea study

Feasibility of management of apnea of prematurity with caffeine citrate at a tertiary health care facility in Kenya. A quality improvement study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202303498806131
Enrollment
200
Registered
2023-03-10
Start date
2021-12-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Neonatal Diseases

Interventions

Baseline data collection

Sponsors

Bill and Melinda Gates Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Neonates admitted to the KNH newborn unit during the study period who are born less than 34 weeks gestational age or with a birthweight less than 1500 grams where the gestational age is unknown and who are estimated to have a gestational age less than 34 weeks by New Ballard Scoring for gestational assessment as per current practice at KNH; Neonates on either aminophylline or caffeine citrate based on existing clinical criteria or clinical events;

Exclusion criteria

Exclusion criteria: Unwillingness or inability of the neonate’s caregiver to provide informed consent for data collection and use. Neonates who would be unlikely to be transferred out of the newborn unit and not accessible for followup

Design outcomes

Primary

MeasureTime frame
A context-appropriate apnea of prematurity clinical care bundle which is acceptable to stakeholders

Secondary

MeasureTime frame
An assessment of feasibility, usability, and acceptability of the apnea of prematurity clinical care bundle that includes monitoring of at-risk neonates and managing apnea of prematurity with caffeine citrate by healthcare administrators, healthcare providers, and caregivers.;Identified barriers to and facilitators for effective implementation of the apnea of prematurity clinical care bundle.

Countries

Kenya

Contacts

Public ContactDorothy Chomba

Research Coordinator

dorothy.chomba@aku.edu+254731856146

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026