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

S

Sarah Keim

Status and phase

Completed
Phase 4

Conditions

Child Development
Child Behavior
Preterm Birth

Treatments

Other: Canola Oil Placebo
Drug: LCPUFA oil supplement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

18 to 39 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

31 participants in 2 patient groups, including a placebo group

LCPUFA Oil Supplement
Experimental group
Description:
EPA + DHA + GLA + OA oil supplement
Treatment:
Drug: LCPUFA oil supplement
Canola Oil Placebo
Placebo Comparator group
Treatment:
Other: Canola Oil Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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