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Comparing two types of ventilation in newborns with varying respiratory support

Comparison of two modes of invasive mechanical ventilation that is Synchronous intermittent mandatory ventilation vs Pressure control or assist control in newborns with hypoxic respiratory failure due to respiratory distress syndrome Open labelled randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067968
Enrollment
82
Registered
2024-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: J984- Other disorders of lung Health Condition 2: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Pressure control/Assist control mode of ventilation: In this mode there is delivery of a synchronized mechanical breath each time a spontaneous is detected (assist) or if patient fails

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A preterm newborn requiring mechanical ventilation due to respiratory distress syndrome within 72 hours of birth.

Exclusion criteria

Exclusion criteria: 1.Surgical anomalies of chest/abdomen, 2.Major extra-thoracic malformation/syndromic newborns 3.Severe perinatal asphyxia

Design outcomes

Primary

MeasureTime frame
1.Duration of mechanical ventilation (mean days of ventilation) 2.Progression of respiratory failure and requirement of High-frequency ventilation Timepoint: hourly data collection till death or till discharge from the NICU

Secondary

MeasureTime frame
1.Survival of preterm newborns who required invasive mechanical ventilation for primary respiratory distress syndrome. 2.Surfactant doses requirements 3.Extubation failure 4.Incidence of pneumothorax 5.Duration of non-invasive respiratory support 6.Progression to Bronchopulmonary dysplasia 7.Extrapulmonary morbidity of Retinopathy of prematurity, intraventricular haemorrhage, and patent ductus arteri 8.Need for sedation or worsening of clinical distress needing augmentation of pressure indicated by tachycardia,tachypnea and hypoxia which suggested inadequate ventilationTimepoint: hourly data collection till death or till discharge from the NICU

Countries

India

Contacts

Public ContactDr Chetan Khare

AIIMS Bhopal

shikha.pediatrics@aiimsbhopal.edu.in9425018080

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026