The Pediatric Development Clinic Study

NCT03665012 | Completed

• 1 other identifier: 222
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, Puerperium and Perinatal Conditions

Outcome Measures

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.

  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 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.

  April 2014 to March 2019

Interventions

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.

Eligibility Criteria

• Age: 1 Week - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All under-five children in need of formal follow-up with the following medical condition will be enrolled in PDC * children born premature * children born with an extremely low birth weight (ELBW)/ very low birth weight (VLBW) * infants born at term with HIE or Central Nervous System infections (cerebral malaria and meningitis) * children with developmental delays, * children with trisomy 21, hydrocephalus, cleft lip/palate * children less than 12 months of age discharged from the hospital following malnutrition treatment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Partners in Health: lead
• Grand Challenges Canada: collaborator

Study Sites (1)

Kirehe District Hospital

Kirehe, Eastern, Rwanda

Location

Related Publications (3)

• 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 Rwanda: a retrospective cohort study. BMC Pediatr. 2018 Feb 16;18(1):65. doi: 10.1186/s12887-018-1007-0.

  PMID: 29452576 RESULT

• 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 developmental outcomes of at-risk under-five children in rural Rwanda. Matern Health Neonatol Perinatol. 2017 Jul 12;3:13. doi: 10.1186/s40748-017-0052-2. eCollection 2017.

  PMID: 28706729 RESULT

• Nemerimana M, Karambizi AC, Umutoniwase S, Barnhart DA, Beck K, Bihibindi VK, Wilson K, Nshimyiryo A, Bradford J, Havugarurema S, Uwamahoro A, Nsabyamahoro E, Kirk CM. Evaluation of an mHealth tool to improve nutritional assessment among infants under 6 months in paediatric development clinics in rural Rwanda: Quasi-experimental study. Matern Child Nutr. 2021 Oct;17(4):e13201. doi: 10.1111/mcn.13201. Epub 2021 May 7.

  PMID: 33960693 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Maternal and Child Health

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: September 11, 2018
• Study Start: April 1, 2017
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)