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Prevention of Developmental Delay and Xylitol (PDDaX) Study

Primary Purpose

Prematurity, Neurodevelopmental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Maternal Use of Xylitol Chewing Gum During Pregnancy
No Maternal Xylitol Chewing Gum Use During Pregnancy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity focused on measuring Xylitol, Oral Health, Pregnancy, Prematurity

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child born during the PPaX trial
  • Enrollment age between 5-8 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

Exclusion Criteria:

  • Parent or legal guardian cognitively unable to provide consent
  • Child unwilling to provide assent to participate in the study

Sites / Locations

  • Baylor College of Medicine Children's Foundation-MalawiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Xylitol-exposed formerly term children

Non xylitol-exposed formerly term children

Xylitol-exposed formerly preterm children

Non xylitol-exposed formerly preterm children

Arm Description

n=250 formerly term children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)

n=250 formerly term children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)

n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)

n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)

Outcomes

Primary Outcome Measures

Validation of the MDAT in Former Preterm Children
compared to the KABC-II
Validation of the MDAT in Former Term Children
compared to the KABC-II
KABC-II mental processing index
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
EF Touch composite score
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
SDQ composite
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
MDAT composite neurodevelopmental outcome
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed

Secondary Outcome Measures

Incidence of cognitive delay per specific KABC-II subdomain
sequential processing (working memory), simultaneous processing (visual processing), planning ability (fluid reasoning), and learning ability (long-term memory and retrieval)
Incidence of executive function delay per specific EF Touch subdomains
processing speed ("Bubbles"), visual spatial working memory ability ("Farmer"), working memory ("Pick the Picture" and "Houses"), inhibitory motor control ("Pig", "Silly Sounds Game", and "Arrows"), and Flexible thinking ("Something's the Same")
Incidence of social-emotional delay per specific SDQ subdomains
Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior
Incidence of neurodevelopmental delay as per MDAT subdomains
Gross motor, fine motor, social, and language

Full Information

First Posted
April 27, 2022
Last Updated
April 12, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05361122
Brief Title
Prevention of Developmental Delay and Xylitol (PDDaX) Study
Official Title
Prevention of Developmental Delay and Xylitol (PDDaX) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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). The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Neurodevelopmental Disorders
Keywords
Xylitol, Oral Health, Pregnancy, Prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will enroll 1000 children aged 4-8 years of age. n=500 will be former term children and additional n=500 will be former preterm children. Half in each group (n=250) will be gestationally xylitol-exposed, and the other half (n=250) will not be xylitol-exposed.
Masking
Care Provider
Masking Description
Psychologists and dentists will be blinded to the treatment status (xylitol or no xylitol use during pregnancy) of the mothers of the pediatric subjects.
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylitol-exposed formerly term children
Arm Type
Experimental
Arm Description
n=250 formerly term children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)
Arm Title
Non xylitol-exposed formerly term children
Arm Type
Active Comparator
Arm Description
n=250 formerly term children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)
Arm Title
Xylitol-exposed formerly preterm children
Arm Type
Experimental
Arm Description
n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)
Arm Title
Non xylitol-exposed formerly preterm children
Arm Type
Active Comparator
Arm Description
n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)
Intervention Type
Dietary Supplement
Intervention Name(s)
Maternal Use of Xylitol Chewing Gum During Pregnancy
Intervention Description
There are no current interventions within this follow-up study. However, the mothers enrolled in the parent PPaX trial received xylitol-containing chewing gum (1 gram per stick of gum and instructed to chew 1-2 sticks of gum twice daily for a total dose of 2-4 grams/day of xylitol throughout pregnancy starting pre-conception or at <20 weeks gestation).
Intervention Type
Dietary Supplement
Intervention Name(s)
No Maternal Xylitol Chewing Gum Use During Pregnancy
Intervention Description
There are no current interventions within this follow-up study. Children born to mothers who received access to a dentist and prenatal education (oral health, prevention of preterm birth) are in the active comparator group
Primary Outcome Measure Information:
Title
Validation of the MDAT in Former Preterm Children
Description
compared to the KABC-II
Time Frame
1 month (1-2 clinic visits)
Title
Validation of the MDAT in Former Term Children
Description
compared to the KABC-II
Time Frame
1 month (1-2 clinic visits)
Title
KABC-II mental processing index
Description
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
Time Frame
1 month (1-2 clinic visits)
Title
EF Touch composite score
Description
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
Time Frame
1 month (1-2 clinic visits)
Title
SDQ composite
Description
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
Time Frame
1 month (1-2 clinic visits)
Title
MDAT composite neurodevelopmental outcome
Description
In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
Time Frame
1 month (1-2 clinic visits)
Secondary Outcome Measure Information:
Title
Incidence of cognitive delay per specific KABC-II subdomain
Description
sequential processing (working memory), simultaneous processing (visual processing), planning ability (fluid reasoning), and learning ability (long-term memory and retrieval)
Time Frame
1 month (1-2 clinic visits)
Title
Incidence of executive function delay per specific EF Touch subdomains
Description
processing speed ("Bubbles"), visual spatial working memory ability ("Farmer"), working memory ("Pick the Picture" and "Houses"), inhibitory motor control ("Pig", "Silly Sounds Game", and "Arrows"), and Flexible thinking ("Something's the Same")
Time Frame
1 month (1-2 clinic visits)
Title
Incidence of social-emotional delay per specific SDQ subdomains
Description
Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior
Time Frame
1 month (1-2 clinic visits)
Title
Incidence of neurodevelopmental delay as per MDAT subdomains
Description
Gross motor, fine motor, social, and language
Time Frame
1 month (1-2 clinic visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 Exclusion Criteria: Parent or legal guardian cognitively unable to provide consent Child unwilling to provide assent to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Greg Valentine, MD
Phone
(206) 543-3200
Email
gcvalent@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Valentine, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine Children's Foundation-Malawi
City
Lilongwe
Country
Malawi
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phoebe Nyasulu
Email
pnyasulu@baylor-malawi.org

12. IPD Sharing Statement

Learn more about this trial

Prevention of Developmental Delay and Xylitol (PDDaX) Study

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