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Comparing two methods of giving support to respiratory system of babies born early , following the removal of respiratory support which was being provided through a tube placed in babys airway

Nasal high frequency oscillatory ventilation(nHFOV) versus non invasive positive pressure ventilation(NIPPV) as a post extubation respiratory support in preterm neonates( 26-37 weeks) admitted in a tertiary care centre â?? A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020055
Enrollment
86
Registered
2019-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: nasal high frequency ventilation: nasal high frequency ventilation will be provided to one group of patient subset obtained after randomization as a post extubation respiratory support

Sponsors

Department of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants born between 26 weeks of gestation and 2. Inborn babies upto postnatal age 15 days 3. Mechanically ventilated for at least 12 hrs

Exclusion criteria

Exclusion criteria: 1.Babies 37 weeks of gestation and gms 2. Outborn babies 3. Major congenital anomalies or known/suspected chromosomal anomalies 4. Upper airway anomalies 5. Severe perinatal asphyxia ( blood gas pH less than 7.0 and BE more than -12 ) 6. Participation in another randomized interventional trial

Design outcomes

Primary

MeasureTime frame
Extubation failure within 72 hoursTimepoint: 72 hours—

Secondary

MeasureTime frame
ALL CAUSE MORTALITYTimepoint: TILL DISCHARGE;BPDTimepoint: till discharge;INVASIVE VENTILATOR DAYSTimepoint: TILL DISCHARGE;IVH GRADE 3 AND ABOVE (on TcUSG)Timepoint: TILL DISCHARGE;NEC STAGE 2 AND ABOVE, GASTROINTESTINAL PERFORATION( confirmed on xray or surgical exploration), ABDOMINAL DISTENSION more than 2cm (necessitating cessation of feeding in first 48 hours post extubation)Timepoint: till discharge;NICU LENGTH OF STAYTimepoint: TILL DISCHARGE;PULMONARY AIR LEAKTimepoint: TILL RESPIRATORY SUPPORT REQUIREMENT;ROP, ANY STAGETimepoint: TILL DISCHARGE—

Countries

India

Contacts

Public ContactSOUTRIK SETH

SSKM-IPGMER, KOLKATA

bijansaha18@gmail.com9051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026