Benefits of physiotherapy techniques and movement therapy on breathing and overall development of premature babies

Not yet recruiting

Conditions: Respiratory distress syndrome of newborn,

Registration Number: CTRI/2020/09/027994

Lead Sponsor: Manasa K R

Brief Summary: 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 infantâ€™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 infantâ€™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 infantâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Very preterm infants, Gestational age â€“ 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 â€“ 4 months follow up Sample size: 12 1. Parents who are able to comprehend simple instructions 2. Has functional reading comprehension and communication in English/Kannada 3. Willing to participate.

Exclusion Criteria

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 â€“ 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Modified Downes score	Everyday, before and after the intervention during 26 to 32 weeks
2. Silverman Anderson score	Everyday, before and after the intervention during 26 to 32 weeks

Secondary Outcome Measures

Name	Time	Method
1. Prechtlâ€™s General Movement Assessment (GMA)	2. Neurobehavioral assessment of the Preterm Infant (NAPI)

Trial Locations

Locations (1): Kasturba Medical Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical Hospital
🇮🇳Udupi, KARNATAKA, India
Manasa K R
Principal investigator
9535192550
manasa.kolibylu@learner.manipal.edu