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Prevention study for Prematurity
Official title Prevention of Developmental Delay and Xylitol (PDDaX) Study
ClinicalTrials.gov ID: NCT05361122
What this study is testing
- What it's testing
- The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 8
You may be able to join if
- Child born during the PPaX trial
- Enrollment age between 4-8 years old
- Parental or legal guardian consent obtained
- Willing to undergo 3 neurodevelopmental tests
- Willing to travel to BCMF for neurodevelopmental assessment
You likely can't join if
- Parent or legal guardian cognitively unable to provide consent
- Child unwilling to provide assent to participate in the study
See the full eligibility criteria
- Child born during the PPaX trial
- Enrollment age between 4-8 years old
- Parental or legal guardian consent obtained
- Willing to undergo 3 neurodevelopmental tests
- Willing to travel to BCMF for neurodevelopmental assessment
- Assent by the pediatric subject for participation in the study
- Parent or legal guardian cognitively unable to provide consent
- Child unwilling to provide assent to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Lilongwe, Malawi
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 8 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lilongwe, Malawi. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.