Clinical trial NCT01683565: Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Official title: Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Child Development
Child Behavior
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cures Within Reach
name: Marci and Bill Ingram Fund for Autism Spectrum Disorders Research
First posted: 2012-09-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
timeFrame: Baseline to 90 days post randomization
measure: Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
timeFrame: Baseline to 90 days post randomization
Secondary outcomes:
measure: Fatty Acid
timeFrame: Baseline to 90 days post randomization
Other outcomes:
measure: Feasibility: Future Full-scale Multi-site Study
timeFrame: Pre-baseline to 90 days post randomization
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial. Early Hum Dev. 2022 Jun;169:105588. doi: 10.1016/j.earlhumdev.2022.105588. Epub 2022 May 19.
citation: Keim SA, Gracious B, Boone KM, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Sheppard KW, Husk J, Rhoda DA. omega-3 and omega-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers. J Nutr. 2018 Feb 1;148(2):227-235. doi: 10.1093/jn/nxx047.
citation: Boone KM, Gracious B, Klebanoff MA, Rogers LK, Rausch J, Coury DL, Keim SA. Omega-3 and -6 fatty acid supplementation and sensory processing in toddlers with ASD symptomology born preterm: A randomized controlled trial. Early Hum Dev. 2017 Dec;115:64-70. doi: 10.1016/j.earlhumdev.2017.09.015. Epub 2017 Sep 20.