Combining Neonatal Neurobehavioral (Brazelton) And Motor Behavior (Prechtl) In The Assessment And Ultra Early Physical Therapy Intervention Of Premature Infants
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- The neonatal behavioural assessment scale (NBAS)
研究概览
简要总结
Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.
详细描述
Developments in neonatology and perinatal medicine in recent years have resulted in a remarkable development of the survival of premature infants. At the same time, several evaluation and intervention protocols have been developed, aiming at early diagnosis and intervention, but also and studies that are concluding and highlight the need for future well planed and in-depth research, mainly in areas related to early intervention. T. Brazeltons' (1973) Neonatal Behavioural Assessment Scale (NBAS) has been used in many studies of assessment and intervention in newborn-infant and their families and respectively H.R. Prechtls' (1979) Qualitative Assessment of General Movements (GMs) in assessment studies, as a valid and reliable non-invasive procedure. However, the combination of their basic principles and guidelines has not been developed and tested in the context of ultra-early physiotherapy intervention in premature infants.
The evaluation and strengthening of ultra-early physiotherapy intervention by combining basic principles of neonatal neuro-behavior (based on Brazelton T.) and motor behavior (based on Prechtl H.F.R.), in the context of individualized and developmental supportive care of premature neonates and infants and enhancing parental self-confidence.
The research is based upon on three different researches: a) the cross-cultural adaptation of Karitane Parental Confidence Scale (KPCS) questionnaire. The sample will be parents of infants up to one year, b) the effect of ultra-early intervention on parental confidence of preterm infant parents. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) until maternity hospital discharge. The sample will be premature infants and their parents and c) the effect of ultra-early intervention and parental confidence, on the development of premature infants up to the age of three months. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) and upon their discharge from the maternity hospital up to the age of 3 months. The study sample will be premature infants and their parents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
prematurity (NICU)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age under 37 weeks
- •Premature newborns hospitalised in the NICU for at least eight days
- •(for parents) be able to speak and read Greek or English
排除标准
- •Newborns with congenital and chromosomal abnormalities.
- •Newborns with severe accompanying pathological problems and congenital infections.
- •(for parents) with known history of drug or alcohol abuse or serious psychiatric disorders
结局指标
主要结局
The neonatal behavioural assessment scale (NBAS)
时间窗: newborn - 2 month old (corrected age)
Assesses neurobehavioral repertoire of the newborn
The New-born Behavioral Observations (NBO)
时间窗: Βirth through the 3rd month of life
latest and inspired by the clinical uses of NBAS. Αn interactive relationship-building tool to strengthen the relationship between infants and parents beginning in the newborn period
The Qualitative Assessment of General Movements (GMsA)
时间窗: birth to 20 weeks (corrected age)
non-invasive and non-disruptive assessment through observations of the quality of generalised movements to determine the integrity of the CNS of infants
• Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)
时间窗: Birth to 12 months
Assesses perceived parental confidence in newborn/infant care
• Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)
时间窗: From Enrollment to the end of interventional 3 months
Parental Self Reported Questionnaire concerning their experiences in NICU
次要结局
- Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)(From enrollment to the end of program at 3 months)
研究者
Moscholouri Chrysoula
Principal Investigator
University of Thessaly