跳至主要内容
临床试验/CTRI/2020/09/027994
CTRI/2020/09/027994尚未招募不适用

Effect of Neurophysiological Facilitation techniques and Movement Imitation Therapy on respiratory function and neuromotor development in preterm infants - A randomized controlled trial

Manasa K R1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Modified Downes score

研究概览

简要总结

Premature birth is a critical concern affecting newborn and maternal health, predominantly in developing countries. Respiratory morbidity is a common consequence of prematurity. The development and function of the upper body and ribcage are interrelated with the abdomen and lower body. Neurophysiological facilitation technique is the application of external proprioceptive and tactile stimuli which normalizes the rate and depth of breathing. Movement Imitation Therapy is a novel approach that involves mimicking of fluent and variable general movement sequences. This might optimize motor repertoire and neuromotor development.

Need of the study:

  1. Considering the differences in respiratory system development/ orientation/ properties, preterm infants need prolonged ventilation. Promoting respiratory muscle function, better ventilation-perfusion match, and reduction in the work of breathing may facilitate early weaning from ventilation.

  2. An early stimulation program with a range of motion exercises addressing a uniaxial range of movements is established among newborns. But it is important to facilitate multi-axial, variability of movements in preterm infants.

  3. The altered orientation of the ribcage might affect an infant’s base of support, thereby promoting adequate muscle tone of the ribcage and extremities which may positively enhance: trunk control, self-regulation, and oral feeding skills. Hence, addressing the ribcage from birth might influence an infant’s overall neuromotor development.

Objectives of the study:

Primary objectives

  1. To study the effect of Neurophysiological Facilitation techniques on respiratory function in preterm infants of 26 - 30 weeks of gestation.

  2. To determine the effect of Neurophysiological Facilitation techniques on non-invasive modes of ventilation

Secondary objectives

  1. To study the effect of Movement Imitation Therapy on neuromotor and neurobehavior function in preterm infants when attained 34 weeks of gestation.

  2. To understand the parental experience in delivering the two different early stimulation programs during follow up at 6 months of age.

Hypothesis and Importance of the Study:

  1. If the Neurophysiological facilitation (NPF) technique is found to be an effective intervention, it might reduce the number of days of hospitalization (cost-effective) and thus the burden of the parents.

  2. If minimal intervention like Movement Imitation therapy (MIT) is administered by the parents, it might reduce the infant’s exercise energy expenditure and promote coordinated stability and mobility of the ribcage and extremities.

  3. A combination of NPF and MIT might prevent the occurrence of ribcage irregularities, supports respiratory function, and promote optimal neuromotor development among preterm infants.

  4. Understanding parental experience of delivering early stimulation program can be a value addition for structuring or designing the early stimulation program.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • •1.Very preterm infants, Gestational age – 26 to 30 weeks 2.Birth weight >750 grams 3.Invasive / non-invasive modes of ventilation Understanding of parental experience in delivering the early stimulation program-Secondary Objective Study design: Qualitative in-depth interview Study setting: Neonatal Intensive Care and Pediatric Physiotherapy outpatient department, Kasturba Hospital, Manipal Subjects: Parents of preterm infants from both the groups with low, average & high scores of HINE & BSID.
  • •III Sampling method: Purposive Time of interview: 3 – 4 months follow up Sample size: 12
  • •Parents who are able to comprehend simple instructions
  • •Has functional reading comprehension and communication in English/Kannada
  • •Willing to participate.

排除标准

  • •1.Uncompensated acid-base balance 2.Bradycardia or tachycardia (<80 bpm and >180bpm) 3.Cardiac arrest survivor 4.Untreated/symptomatic congenital heart disease 5.Diaphragmatic hernia 6.Severe congenital anomalies Understanding of parental experience in delivering the early stimulation program-Secondary Objective Study design: Qualitative in-depth interview Study setting: Neonatal Intensive Care and Pediatric Physiotherapy outpatient department, Kasturba Hospital, Manipal Subjects: Parents of preterm infants from both the groups with low, average & high scores of HINE & BSID.
  • •III Sampling method: Purposive Time of interview: 3 – 4 months follow up Sample size: 12 1.Parents who are not able to comprehend simple instructions 2.Not able to read and write 3.Not willing to participate.

结局指标

主要结局

1. Modified Downes score

时间窗: Everyday, before and after the intervention during 26 to 32 weeks

2. Silverman Anderson score

时间窗: Everyday, before and after the intervention during 26 to 32 weeks

次要结局

  • 1. Prechtl’s General Movement Assessment (GMA)(2. Neurobehavioral assessment of the Preterm Infant (NAPI))

研究者

发起方
Manasa K R
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验

Benefits of physiotherapy techniques and movement... | 临床试验