The Pediatric Development Clinic Study

Completed

• Conditions: Pregnancy, Puerperium and Perinatal Conditions

• Registration Number: NCT03665012
• Lead Sponsor: Partners in Health

Brief Summary

Many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers.

Detailed Description

Neonatal health and improving neonatal mortality has become one of the top priorities globally. In Rwanda, hospital care has advanced significantly with the development of national neonatal care guidelines and widespread provider training. As advances in technology and resuscitation become more commonly available, many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers. Prior to implementation, a community-based descriptive study assessing the baseline medical, nutritional and developmental needs of low-birth weight and preterm infants who are the target population of the pediatric development clinic was conducted (Baseline Phase One). Subsequently, after 1-2 years of implementation an evaluation of clinical, nutritional and developmental outcomes of children followed in PDC will be conducted in comparison with the baseline study outcomes (Post-PDC Phase Two). Ongoing research on PDC implementation will focus on research on patient and provider experiences, overall clinic processes, cost-effectiveness, expansion of the PDC model, decentralization to health centers, and longer term outcomes of children enrolled in the PDC to further help refine the PDC model (Post-PDC Phase Three)

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-11
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• All under-five children meeting PDC referral criteria as described in the study population description will be enrolled in PDC.

Exclusion Criteria

• Patients who do not meet referral criterial for PDC or who are over age 5 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare developmental outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population.	April 2014 to March 2019	Proportion of children who are on track developmentally measured by the Ages and Stages Questionnaire Version 3 (ASQ-3) and Caregiver Reported Early Childhood Development Index (CREDI).

Secondary Outcome Measures

Name	Time	Method
To compare nutritional outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population.	April 2014 to March 2019	Proportion of children with normal nutritional status based on anthropometric measures and World Health Organization Growth Standards: weight-for-age (underweight) or weight-for-height (wasting) or length/height-for-age (stunting) z-scores \< -2 (undernutrition) vs healthy (z-score \>-2).

Trial Locations

Locations (1)

Kirehe District Hospital; 🇷🇼 Kirehe, Eastern, Rwanda