The Pediatric Development Clinic Study

Pregnancy, Puerperium and Perinatal Conditions Clinical Trial

— PDC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665012
• Other study ID #: 222
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: August 12, 2019

Study information

• Verified date: September 2019
• Source: Partners in Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, Puerperium and Perinatal Conditions

Intervention

Other:
• Pediatric Development Clinic (PDC)
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.

Locations

Country	Name	City	State
Rwanda	Kirehe District Hospital	Kirehe	Eastern

Sponsors (2)

Lead Sponsor	Collaborator
Partners in Health	Grand Challenges Canada

Country where clinical trial is conducted

Rwanda, 

References & Publications (2)

Bayitondere S, Biziyaremye F, Kirk CM, Magge H, Hann K, Wilson K, Mutaganzwa C, Ngabireyimana E, Nkikabahizi F, Shema E, Tugizimana DB, Miller AC. Assessing retention in care after 12 months of the Pediatric Development Clinic implementation in rural Rwan — View Citation

Ngabireyimana E, Mutaganzwa C, Kirk CM, Miller AC, Wilson K, Dushimimana E, Bigirumwami O, Mukakabano ES, Nkikabahizi F, Magge H. A retrospective review of the Pediatric Development Clinic implementation: a model to improve medical, nutritional and develo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	April 2014 to March 2019
Secondary	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.	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).	April 2014 to March 2019