Pregnancy, Puerperium and Perinatal ConditionsPDCNCT03665012
The Pediatric Development Clinic Study
An observational study of Pregnancy, Puerperium and Perinatal Conditions, run by Partners in Health at 1 site in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 1 week to 5 years
- Conditions the study is for
- Pregnancy, Puerperium and Perinatal Conditions
- What is being tested?
- Pediatric Development Clinic (PDC)
- How many people
- 376 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Apr 2017to 12 Aug 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All under-five children meeting PDC referral criteria as described in the study population description will be enrolled in PDC.
Who cannot join
- Patients who do not meet referral criterial for PDC or who are over age 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda
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.
Read the 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)
- Being tested
- Pediatric Development Clinic (PDC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: April 2014 to March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Apr 2017
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, Puerperium and Perinatal ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Partners in Health
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Catherine Kirk, Partners in Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665012
- Sponsor's protocol ID
- 222
- Acronym
- PDC
- Status last verified
- Sep 2019
- First submitted
- 11 Oct 2017
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29452576Ngabireyimana 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.
PubMed 28706729Nemerimana 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.
PubMed 33960693
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda
- ClinicalTrials.gov ID
- NCT03665012
- Acronym / sponsor ID
- PDC / 222
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Partners in HealthUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 week to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All under-five children meeting PDC referral criteria as described in the study population description will be enrolled in PDC.
Key exclusion criteria (1 listed)
- Patients who do not meet referral criterial for PDC or who are over age 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Results publication: PubMed 29452576Bayitondere 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.
- Results publication: PubMed 28706729Ngabireyimana 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.
- Derived from this study: PubMed 33960693Nemerimana 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Puerperium and Perinatal Conditions, run by Partners in Health at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665012, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.