Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Preterm Birth Clinical Trial

Official title:

Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683565
• Other study ID #: 752311
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: January 2017

Study information

• Verified date: December 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 39 Months

Eligibility

Inclusion Criteria:

1. Child born at less than or equal to 29 completed weeks' gestation;

2. Child between 18 months, 0 days and 38 months, 30 days old chronological age;

3. Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.

4. Child showing some autistic symptoms;

5. Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;

6. English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and

7. Have informed consent on file.

Exclusion Criteria:

1. Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;

2. Unable to tolerate venipuncture;

3. Any major malformation that would preclude participation;

4. Cerebral Palsy (quadriparesis only);

5. Deafness;

6. Blindness;

7. Bleeding disorder;

8. Type I diabetes;

9. Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;

10. Non febrile seizure in the last month without a clear and resolved etiology;

11. Feeding problem that may inhibit full participation;

12. Known fish allergy;

13. Known canola/rapeseed allergy or sensitivity; or

14. Recorded score of <70 on Bayley Cognitive Section within the past year.

Related Conditions & MeSH terms

• Child Behavior
• Child Development
• Premature Birth
• Preterm Birth

Intervention

Drug:
• LCPUFA oil supplement
2.5mL per day for 90 days Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)

Other:
• Canola Oil Placebo
2.5mL per day for 90 days

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Sarah Keim	Cures Within Reach, Marci and Bill Ingram Fund for Autism Spectrum Disorders Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility: Future Full-scale Multi-site Study	Feasibility of a future full-scale multi-site study is assessed by examining the number of children screened, the proportion of these children who screen positive for ASD, the number of children who agree to participate in the trial, the number of children who return for the second and third study visits, baseline differences in individual fatty acids between the intervention and comparison groups, and adherence to the assigned treatment.	Pre-baseline to 90 days post randomization
Primary	Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2	The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.	Baseline to 90 days post randomization
Primary	Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)	Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.	Baseline to 90 days post randomization
Secondary	Fatty Acid	The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit.	Baseline to 90 days post randomization