Effect of physiotherapy exercises on brain development of pretem newborn babies
- Conditions
- Preterm Infants born between 32 week 0 days of gestation to 36 week 6 days of gestationPreterm [premature] newborn [other],
- Registration Number
- CTRI/2016/07/007070
- Lead Sponsor
- School of Allied Health Sciences
- Brief Summary
According to World Health Organisation, 85% of the total preterm births belong to moderate to late preterm category worldwide. India is at the top of the list with number estimated to be 2,959,300 per year. Moderate to late preterm infants were believed to have fewer problems postnatally and were considered equivalent to their term counterparts. Hence they were always managed with routine newborn care and never received the type of attention they deserved. Literature has documented the risks and morbidities of this group. Thus care should be targeted towards managing their physiological stability and ensuring proper neurodevelopment. There is very limited data about the early intervention care provided by neonatal physiotherapists in NICU. Early intervention is an umbrella term for Positioning, swaddling, range of motion, massage, auditory, tactile, visual,vestibular and oromotor stimulation. These interventions are aimed at providing the modulated and paced sensory motor experience to protect the maturation and architecture of infant’s brain. Most of the literature is available on gestation less than 32 weeks and moreover from the western nations. The obstetric and newborn care practised in these countries is quite different from a developing country like India. Thus there is an immense need to conduct a study, which will deal with all the problems of moderate to late preterm infants. Keeping these areas into consideration, a study has been planned which aims at application of structured neonatal physiotherapy recommendations provided by American Physical Therapy association and its effects on the neurodevelopment of moderate to late preterm infants.
Potential preterm infants admitted to Kasturba Hospital NICU between 32 weeks 0 day – 36 weeks 6 days of gestation will be screened for inclusion criteria and will be included in the study. Study procedures will be explained in detail to the parents and written informed consent will be obtained from them. Demographic details of infants will be collected. Baseline assessment will be done using NAPI and Prechtl’s videographic Method on the Qualitative Assessment of General Movements in Preterm, Term and Young Infants. After baseline assessment, the infant will be randomly allocated to either control group or intervention group using block randomisation. Following randomisation, intervention will be performed. The infants assigned to the control group will continue to receive the routine medical and nursing care consisting of traditional positioning, traditional massage. Participants in the intervention group will receive structured neonatal physiotherapy intervention from 32 weeks till discharge designed by American Physical Therapy Association.At the time of discharge, infant both in control as well as intervention group will be evaluated for neuromotor status again using Prechtl’s and NAPI scale.Parents will be provided with pamphlets of home program. Home program pamphlets will contain description regarding stimulation techniques and facilitation of age appropriate milestones for 0-3 month and 4- 6 month. Compliance will be maintained through log book and regular phone calls. Reminder calls will be given for 3 month and 6 month follow up. At 3 month follow up visit, assessment for general movement will be done using Prechtl’s Method and neuromotor development will be evaluated using (BSID- III). At 6 month follow up visit, final neuromotor development will be assessed using BSID –III and results will be compared between control group and treatment group. Children with developmental delay if any will be identified and their parents will be advised to come for regular physiotherapy treatment in Paediatric Physiotherapy Department, Kasturba Hospital, Manipal.
This study will help us to prove the efficacy of structured Neonatal physiotherapy intervention which later on can be incorporated as a routine standard care for moderate to late preterm infant admitted in level III NICU. It will also help us in early identification of infants at risk of developmental delay in the follow up period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Medically stable preterm neonates admitted to Kasturba hospital and born between 32weeks 0 day – 36 weeks 6 days of gestational age.
- •Requirement of oxygen and ventilation at 36 weeks gestational age •Infants with genetic/chromosomal disorders •Congenital anomalies.
- •Significant neurological/musculoskeletal insult during follow up period ( from time of discharge to 6 months of age).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neurobehavior and neuromotor development of preterm infant using Neurobehavioral Assesment of Preterm Infant scale (NAPI) and Prechtls method of Qualitative asessment of General movements in preterm and term infants At baseline and discharge from the hospital
- Secondary Outcome Measures
Name Time Method Neuromotor and cognitive status using Prechtls method of qualitative analysis of General movements and Bayley Scale of Infant& Toddler Development - 3rd Edition (BSID -III) 3 month and 6 month of age
Trial Locations
- Locations (1)
Kasturba Medical College and Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College and Hospital🇮🇳Udupi, KARNATAKA, IndiaDr Leslie Edward LewisPrincipal investigator919449208476leslie.lewis@manipal.edu