Skip to content

Continuation of pre-existing breathing support during elective insertion of breathing tube in immature infants

Continuation of non-invasive ventilatory support to prevent physiological instability during elective intubation in preterm infants - a Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060931
Enrollment
68
Registered
2023-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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: Respiratory support group: Continuation of preexisting Non-Invasive respiratory support (NIPPV/CPAP) with appropriate interface during the attempt of elective intubation. Control Interv

Sponsors

Institute of Post Graduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants (less than 37 completed weeks at birth) already on NIPPV or CPAP requiring elective intubation in first 28 days of life.

Exclusion criteria

Exclusion criteria: Preterm infants undergoing intubation in delivery room. ; Preterm infants undergoing emergency intubation for resuscitation ; Preterm infants intubated directly from room air without any prior respiratory support ;Preterm infants intubated from HHHFNC ; Preterm infants intubated beyond first 28 days of life.; Major congenital anomalies. ; Cyanotic congenital heart disease. ; Contradictions to non-Invasive respiratory support eg. Congenital diaphragmatic hernia, abdominal wall defects, choanal atresia etc.; Infants with suspected or proven COVID-19, born to a mother with suspected or proven COVID-19.

Design outcomes

Primary

MeasureTime frame
Percentage of successful intubation at first attempt without physiological instability , defined by heart rate 20% from the immediate pre laryngoscopy baseline level.Timepoint: time taken during intubation

Secondary

MeasureTime frame
Feasibility of the intervention ; Number of intubation attempts ; Median oxygen saturation during intubation attempts ; Median heart rate during intubation attempts ; Duration of intubation attempts ; Duration of desaturation and bradycardia during intubation attempt ; requirement of CPR ; Pneumothorax or deathTimepoint: time taken during intubation

Countries

India

Contacts

Public ContactAdrita Bose

Institute of Post Graduate Medical Education and Research

syamalsardar@gmail.com9434306529

Outcome results

None listed

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