Effect of Tactile/Kinaesthetic Massage Therapy on Growth Parameters and Body Composition of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Growth parameter (Weight)
研究概览
简要总结
The effect of Tactile/Kinaesthetic massage therapy on weight gain and different components of growth, as assessed by anthropometric measurements and DXA scan, and correlate these components with serum IGF-1, leptin and adiponectin in preterm infants.
详细描述
Prospective open label randomized, single-blind, controlled trial was done in the NICU at Mansoura University Children's Hospital.
Stable preterm infants in the NICU awaiting for sustained pattern of weight gain were included in the study.
Massage therapy was started at corrected gestational age of 35 weeks and continued for 5 consecutive days. The protocol of massage therapy was performed as been described by Tiffany Field. Three consecutive, 15 minutes, sessions were performed daily after the noon feeding. Each treatment session was divided into 5 minutes of tactile stimulation, followed by 5 minutes of kinaesthetic stimulation, and then another 5 minutes of tactile stimulation.
During massage therapy, infant's behavioural reaction was observed for signs of distress (e.g., yawning, finger splaying, crying). Vital signs are measured 15 minutes before, 15 minutes during and 15 minutes after the massage procedure. If signs of physiologic distress developed (heart rate greater than 200 bpm), massage was discontinued for 15 seconds, or until a return to baseline levels.
The study was discontinued if five periods of observed behavioural or physiological stress occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically stable premature infants with gestational age at 28 to 37 weeks' admitted to the "grower" (step-down) nursery. Stability is defined as lack of need for supplemental oxygen, apneas and bradycardias, systemic antimicrobial therapy for infection, or a central line. On at least 100 ml/kg/d of feed (oral or tube feed) preterm formula. informed consent will be obtained from parents before enrollment in the study.
排除标准
- •History of necrotizing enterocolitis, receipt of postnatal steroids, active infection, congenital malformations, chromosomal abnormality, intracranial hemorrhage more than (>) grade 2, inborn errors of metabolism, meningitis or encephalopathy, need for surgery.
结局指标
主要结局
Growth parameter (Weight)
时间窗: 5 days
Daily weight gain in grams and cumulative weight gain after 5 days of intervention
Growth parameter (Length)
时间窗: 5 days
Daily length gain in cm and cumulative length gain after 5 days of intervention
Growth parameter (Head circumference)
时间窗: 5 days
Daily head circumference gain in cm and cumulative head circumference gain after 5 days of intervention
Growth parameter (Ponderal Index)
时间窗: 5 days
Daily changes in Ponderal Index and cumulative changes in Ponderal Index after 5 days of intervention
Growth parameter (Mid-arm circumference)
时间窗: 5 days
Daily mid-arm circumference gain in cm and cumulative mid-arm circumference gain after 5 days of intervention
次要结局
- Dual X-ray absorptiometry scan (DXA scan)(5 days)
- Serum adiponectin(5 days)
- Insulin-like Growth Factor 1 (IGF-1)(5 days)
- Serum Leptin(5 days)
研究者
Nehad Nasef
Associate Professor
Mansoura University Children Hospital