Developmental Family Centred Care Program in Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Parent Infant interaction behaviours coding
研究概览
简要总结
This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
详细描述
Preterm babies, specifically with gestational age < 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B).
When the clinical condition of the child is stable the parents are approached for consent and randomised.
All families (in intervention A and intervention B) will receive the evidence-based program of Family Education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship.
It takes its conceptual basis from the Mother Infant Transaction Program (MITP). It is a specific and re-adapted version for the preterm infant hospitalized in NICU The family education sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NICU directly at the child's bed between the operator and one or both parents. Each meeting involves the discussion of one of the following topics.
The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor) Investigator and Outcomes assessors are blind to the group assignment of the infant. Care provider (Parents and Research staff supporting parents in intervention can not be masked to the group assignment).
入排标准
- 年龄范围
- 1 Week 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of preterm <34 weeks without brain lesion
排除标准
- •Parents of infants with brain Lesions
- •Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- •Parents of infants with genetic-malformative conditions
- •Parents with severe psychiatric disorders
结局指标
主要结局
Parent Infant interaction behaviours coding
时间窗: 6 months corrected age
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Developmental outcome assessment
时间窗: 12 months corrected age
Bayley Scales of Infant Development Third Edition will be conducted including the Cognitive, Language (Receptive \& Expressive), Motor (Gross \& Fine), Social-Emotional and Adaptive sub scales. Each sub scale score will be calculated based on the age (months of age) of the infant at the time assessment. Higher scores mean a better outcome.
次要结局
- Family well-being questionnaires(Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age)
- Family well-being questionnaire(Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age)
研究者
Andrea Guzzetta
Full Professor
University of Pisa