Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sarah Keim
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
研究概览
简要总结
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 39 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child born at less than or equal to 29 completed weeks' gestation;
- •Child between 18 months, 0 days and 38 months, 30 days old chronological age;
- •Child admitted to NICU and/or had a Neonatology Clinic follow up visit scheduled.
- •Child showing some autistic symptoms;
- •Child between the 5th and 95th percentiles (per WHO growth chart) for weight at his/her most recent hospital visit;
- •English spoken in the home, demonstrate ability to communicate in English well-enough to understand study, informed consent, and study questionnaires; and
- •Have informed consent on file.
排除标准
- •Consume LCPUFA supplement drops, chews, powders, Pediasure, or fatty fish more than 2x per week;
- •Unable to tolerate venipuncture;
- •Any major malformation that would preclude participation;
- •Cerebral Palsy (quadriparesis only);
- •Bleeding disorder;
- •Type I diabetes;
- •Fragile X Syndrome, Rett Syndrome, Angelman Syndrome, Tuberous Sclerosis;
- •Non febrile seizure in the last month without a clear and resolved etiology;
- •Feeding problem that may inhibit full participation;
- •Known fish allergy;
- •Known canola/rapeseed allergy or sensitivity; or
- •Recorded score of <70 on Bayley Cognitive Section within the past year.
研究组 & 干预措施
LCPUFA Oil Supplement
EPA + DHA + GLA + OA oil supplement
干预措施: LCPUFA oil supplement (Drug)
Canola Oil Placebo
干预措施: Canola Oil Placebo (Other)
结局指标
主要结局
Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2
时间窗: Baseline to 90 days post randomization
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.
Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
时间窗: Baseline to 90 days post randomization
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.
次要结局
- Fatty Acid(Baseline to 90 days post randomization)
研究者
Sarah Keim
Principal Investigator
Nationwide Children's Hospital