A Community Based Implementation of a Toolkit and Parenting Program for Improving Brain Development in Newborns
1 other identifier
interventional
1,080
1 country
1
Brief Summary
The investigators propose to develop and test the efficacy of a low cost evidence based toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord care, hypothermia management, aspiration and bag and mask techniques and APGAR score calculation. A simple, home-based parenting program will also be implemented that will teach parents tools that provide stimuli for brain and cognitive development in children. This parenting program covers Early Childhood Interventions for children at risk of developmental problems and covers developmental skill areas such as cognitive and fine motor, social and self-help and gross motor skills. Such an intervention package provides comprehensive care to families at the community level, with a minimal cost that can be scaled up. A new cadre of Link workers will be implemented who will provide mentoring and supportive supervision to Birth Attendants and will train parents in the stimulation program. The study will recruit 1080 pregnant women and their newborns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedDecember 2, 2015
November 1, 2015
1.7 years
October 21, 2014
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Bayleys Scale for Infant Development score
one time assessment at infant's 12 month birthday
Secondary Outcomes (2)
HOME inventory test
2 assessments at 6 months birthday and 12 month birthday of the infant
Parent-Child Interaction assessment
2 assessments at 6 months birthday and 12 month birthday of the infant
Study Arms (2)
Parenting program and toolkit
ACTIVE COMPARATORThe intervention arm of the study will have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy and the parenting program delivered to the newborn for 12 months.
Control- toolkit
OTHERThe control arm of the study will only have the low cost evidence based toolkit delivered to the the pregnant women for the duration of their pregnancy.
Interventions
The parenting program is an early childhood stimulation program aimed at newborns from their neonatal period till infancy. The implementation of the parenting program will be conducted through the link workers and parents of the newborns.
The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include: 1. Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials 2. Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask APGAR (also to parents), cord care, basic pregnancy and newborn care information
Eligibility Criteria
You may qualify if:
- Those pregnant women who are starting the second trimester of their pregnancy;
- Those women who will continue to live in the community/village during the pregnancy period and until one year postpartum.
You may not qualify if:
- Those pregnant women who appear to be, in the link worker's judgment, incapable of understanding the information provided about the study (e.g., mentally incapacitated, cognitively impaired etc.)
- Not willing to participate in the study/unwilling to provide informed consent or the consent of their family.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Grand Challenges Canadacollaborator
- Centre for Global Public Health Pakistancollaborator
Study Sites (1)
Center for Global Public Health
Islamabad, 44000, Pakistan
Study Officials
- PRINCIPAL INVESTIGATOR
James F Blanchard, MSc
University of Manitoba
- PRINCIPAL INVESTIGATOR
Tahira E Reza, MSc
Centre for Global Public Health Pakistan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Center Director
Study Record Dates
First Submitted
October 21, 2014
First Posted
November 14, 2014
Study Start
January 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
December 2, 2015
Record last verified: 2015-11