Prevention of Developmental Delay and Xylitol (PDDaX) Study

Prematurity Clinical Trial

Official title:

Prevention of Developmental Delay and Xylitol (PDDaX) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361122
• Other study ID #: STUDY00015305
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: Greg Valentine, MD
• Phone: (206) 543-3200
• Email: gcvalent[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Premature Birth
• Prematurity

Intervention

Dietary Supplement:
• Maternal Use of Xylitol Chewing Gum During Pregnancy
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).
• No Maternal Xylitol Chewing Gum Use During Pregnancy
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

Locations

Country	Name	City	State
Malawi	Baylor College of Medicine Children's Foundation-Malawi	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the MDAT in Former Preterm Children	compared to the KABC-II	1 month (1-2 clinic visits)
Primary	Validation of the MDAT in Former Term Children	compared to the KABC-II	1 month (1-2 clinic visits)
Primary	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	1 month (1-2 clinic visits)
Primary	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	1 month (1-2 clinic visits)
Primary	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	1 month (1-2 clinic visits)
Primary	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	1 month (1-2 clinic visits)
Secondary	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)	1 month (1-2 clinic visits)
Secondary	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")	1 month (1-2 clinic visits)
Secondary	Incidence of social-emotional delay per specific SDQ subdomains	Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior	1 month (1-2 clinic visits)
Secondary	Incidence of neurodevelopmental delay as per MDAT subdomains	Gross motor, fine motor, social, and language	1 month (1-2 clinic visits)