Skip to main content
OpenTrials
Completed

NCT Number: NCT03665012

The Pediatric Development Clinic Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 week–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kirehe District Hospital

Kirehe, Eastern, Rwanda

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pediatric Development Clinic (PDC)

Other

All children enrolled in PDC will be at screened for any medical condition they may have and be referred for treatment as required. Nutrition and development support are also provided to clinic enrollees, based on clinic protocols which include regular monitoring and intervention.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Partners in Health

Other

Collaborators

  • Grand Challenges Canada

Registry information

Official study title

The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda

Acronym: PDC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.