Home Stimulation for Brain-Asphyxiated Infants
Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention
調査の概要
詳細な説明
Although the incidence of brain injury in infants is only 2 to 5 per 1000 births, the legal and medical costs, the developmental delays, and the impact on the family are profound. Twenty to 30% of survivors of brain injury have some long-term neurologic sequelae.
This randomized controlled trial will enroll 120 term and near-term neonates with a history of asphyxia to 1-year of a standard follow-up program (provided by the Los Angeles Regional Centers) or a home-based intervention program (Utah State University's Developmental Curriculum and Monitoring System, CAMS). The experimental intervention will include individualized cognitive/neuromotor stimulation given by the child's parents under the guidance of public health nurses. Following the intervention, measures will be used to determine functional capacity (Bayley II scale and neurologic examination), behavioral outcomes (HOME and NCAST by developmental specialists), and maternal outcomes (including parent-infant interaction and perceived stress). Infants will be assessed after the 1-year intervention by psychologists and physicians masked to the intervention. Functional MRI brain studies will be conducted at discharge and 18 months of age at UCLA to assess qualitative and quantitative sensorimotor representation. Secondary outcomes include care stress and social support as reported by parents, and demographics and medical factors obtained from the hospital records.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90095
- University of California at Los Angeles
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
All of the following criteria must be met:
- Gestation age (GA) at birth >= 28 weeks
- Discharged to home care with parent or other guardian who has legal authority to give informed consent
- Greater than 10th percentile for GA at birth using the scales according to Lubchenco, Hansman, and Boyd from Pediatrics 1966 volume 37 and Battaglia and Lubchenco in the Journal of Pediatrics 1967 volume 71
- Jewelry in pierced body parts can be removed
- Mothers > 17 years old
- Recruited within 60 days of EDC (estimated date of conception)
Two or more of the following must be met:
- Intrapartum distress as determined by placental abruption, thick meconium staining of amniotic fluid, sustained fetal bradycardia of heart rate < 100 beats/min, or late or absent heart rate variability
- Profound metabolic or mixed academia as determined by umbilical artery pH < 7.0, base deficit of > 10 mEq/L or pH < 7.1 and base excess greater than 14 mmol/L within 72 hours of birth, Apgar score < 5 at 5 minutes or beyond, or need for positive pressure ventilation resuscitation for > 1 min after birth
- Neonatal neurological manifestations such as seizures during hospital stay, lethargy, hypotonia or hypertonia, stupor, flaccidity, or decerebration
- Multiple organ system dysfunction
- Abnormal EEG, CT scan, or MRI consistent with hypoxic or ischemic brain insult
Exclusion Criteria:
- Infants of substance abusing mothers (ISAM)
- Intrauterine growth retardation (IUGR)
- Infants requiring extracorporeal membrane oxygenation (ECMO) in the neonatal period
- Hearing or visual impairment
- Congenital cyanotic heart disease with cyanosis and requiring PGE infusion. Children with minimum cardiac structural anomalies (e.g., PDA or VSD or peripheral pulmonary stenosis) will not be excluded from the study.
- Congenital abnormalities of the central nervous system such as congenital hydrocephalus
- Grade IV intraventicular hemorrhage requiring ventriculo-peritoneal shunt (VP shunt)
- Trisomy 13, 18, or 21, or Fragile X
- Metabolic encephalopathy from inborn errors of metabolism (e.g. PKU, OTC)
- Metal or wire mesh implants, pacemaker implants, cochlear implants, orthopedic surgical wires or implants
- Status epilepticus
- Ventilator dependent at discharge
- Infectious meningitis
- Encephalitis with radiological evidence of severe cortical or severe hemispheric destruction
- Silastic catheters, broviacs, or Hickman port home TPA
- Infants who may not be available for the duration of the study
- Any infant who in the opinion of investigator has no potential to benefit from the intervention (e.g., children with prenatal herpes meningitis, severe cortical destruction, mother does not follow up with the intervention or with the follow-up appointments)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
協力者と研究者
捜査官
- 主任研究者:Meena Garg, MD、University of California at Los Angeles
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NICHD-0115
- 1R01HD038600-01 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。