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The Pediatric Development Clinic Study (PDC)

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ClinicalTrials.gov Identifier: NCT03665012
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
Grand Challenges Canada
Information provided by (Responsible Party):
Catherine Kirk, 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.

Condition or disease Intervention/treatment
Pregnancy, Puerperium and Perinatal Conditions Other: Pediatric Development Clinic (PDC)

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)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 15, 2019

Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665012


Contacts
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Contact: Catherine Kirk, MPH +250 787113469 ckirk@pih.org

Locations
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Rwanda
Kirehe District Hospital Recruiting
Kirehe, Eastern, Rwanda
Contact: Patient Ngamije, MD    +250 788481736    ngamika@gmail.com   
Contact: Silas Havugarurema, RN    +250 782223803    havugarurema.silas@yahoo.com   
Sponsors and Collaborators
Partners in Health
Grand Challenges Canada
  Study Documents (Full-Text)

Documents provided by Catherine Kirk, Partners in Health:

Additional Information:

Publications of Results:
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Responsible Party: Catherine Kirk, Director of Maternal and Child Health, Partners in Health
ClinicalTrials.gov Identifier: NCT03665012     History of Changes
Other Study ID Numbers: 222
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual children data can only be shared on request according to the Rwandan policy on data sharing. However, study findings will be shared in different meetings, conferences and journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No