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Physiotherapy rehabilitation management in neonatal respiratory distress syndrome

Effect of Physical Rehabilitation using Oro Motor Stimulation, Manual Airway Clearance Technique, Positioning, Tactile and Kinesthetic Stimulation (PROMPT) protocol on Respiratory and Neuromuscular Function in Neonatal Respiratory Distress Syndrome (NRDS)- A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064911
Enrollment
38
Registered
2024-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: PROMPT Protocol: Oromotor stimulation, Manual Airway Clearance technique, Positioning, Tactile and Kinesthics stimulation for 4weeks continuously fro 30 minutes Intervention2: Medical t

Sponsors

Datta Meghe Institute of Higher Education and Research (DU)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: b) Vital Signs: Inclusion criteria involve neonates with a pulse rate (PR) surpassing 160 beats per minute, a respiratory rate (RR) exceeding 60 breaths per minute or exhibiting apnea, and a diastolic blood pressure (DBP) below 60 mm Hg. c) Chest Examination: Eligibility encompasses neonates displaying reduced bilateral or unilateral airway entry, abnormal sounds such as grunting, indications of intercostal retractions, substernal retractions, suprasternal retractions, and nasal flaring. Additionally, X-ray findings indicating white lungs, fine reticular granularity of the parenchyma, and airway bronchograms are considered. d) Skin Examination: Neonates with pale or bluish-colored skin are candidates for inclusion. e) ABG Analysis: Inclusion criteria cover neonates with arterial blood pH below 7.20, arterial blood PCO2 of 60 mm Hg or higher, arterial blood PO2 of 50 mm Hg or less, and an oxygen saturation ranging from 70% to 100%.

Exclusion criteria

Exclusion criteria: a) Significant Congenital Abnormalities b) Profound Hemodynamic Instability c) Life-Threatening Situations: Neonates with urgent and critical medical conditions other than NRDS, necessitating immediate interventions, may be ineligible.

Design outcomes

Primary

MeasureTime frame
Ballard Score Oral Motor Assessment ScaleTimepoint: Baseline, 1st week, 2nd week,3rd week and 4th week

Secondary

MeasureTime frame
APGAR Score Neonatal Network scaleTimepoint: Baseline, 1st week, 2nd week,3rd week and 4th week

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: Mar 14, 2026