Skip to content

Mothers and health care training in neonates with respiratory distress syndrome

Evaluation of Comparative Efficacy of Health Care Delivery by Mothers Versus Trained Health Care Workers in Adjunct to Vojta Therapy on Clinical Outcomes in Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078619
Enrollment
168
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Trained Health Care Worker+Maternal Participation in Health Care: includes multimodal stimulation daily infant development technique, following training from the paediatric physiotherap
otherwise, they receive retraining and re-evaluation. This regimen continues until discharge. Duration-4weeks Control Intervention1: Vojta: The reflex roll from the supine positionâ??Phase I, from sid
phase II, III, and IV, with reflex activation of two or three points. Health Care Delivery by Mothers and Trained Health Care Worker includes multimodal stimulation daily infant development technique,
otherwise, they receive retraining and re-evaluation. This regimen continues until discharge. Duration-4weeks

Sponsors

Datta Meghe Institute of Higher Education and Research DU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Preterm birth less than 36 weeks of gestational age. b) Clinical diagnosis of NRDS C) Spontaneously breathing neonates not requiring invasive mechanical ventilation at the time of enrolment. d) Presence of respiratory distress defined by a Silverman Andersen score between one and seven (mild to moderate respiratory distress) e) Hemodynamically stable at the time of enrolment. g) Expected NICU stay of atleast 20 days to allow completion of the intervention protocol h) The mother and the assigned health care provider must achieve a competency score of nine by ten on a standardised skill assessment conducted by a pedaitric physiotherapist following structured training.

Exclusion criteria

Exclusion criteria: Significant Congenital Abnormalities and profound Hemodynamic Instability b) Life-Threatening Situations: Neonates with urgent and critical medical conditions other than NRDS, necessitating immediate interventions, may be ineligible. c) Serious Neurological Complications: Neonates with severe neurological issues that could independently affect neuromuscular function, apart from NRDS, may be excluded.

Design outcomes

Primary

MeasureTime frame
Silverman-Anderson Respiratory Severity Score (RSS) ii. Bayley Scale of Infant developmentTimepoint: Baseline At the end of discharge

Secondary

MeasureTime frame
Oral motor assessment scaleTimepoint: Baseline At the end of discharge

Countries

India

Contacts

Public ContactDr Sharath Hullumani V

Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)

irshadphysio@rediffmail.com9406010010

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026