The Pediatric Development Clinic Study (PDC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03665012|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment|
|Pregnancy, Puerperium and Perinatal Conditions||Other: Pediatric Development Clinic (PDC)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
- 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.
- 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).
- 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).
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
|Contact: Catherine Kirk, MPH||+250 firstname.lastname@example.org|
|Kirehe District Hospital||Recruiting|
|Kirehe, Eastern, Rwanda|
|Contact: Patient Ngamije, MD +250 788481736 email@example.com|
|Contact: Silas Havugarurema, RN +250 782223803 firstname.lastname@example.org|