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To compare effectiveness of Ram cannula vs nasal mask in preterm neonates with respiratory distress

â??RAM cannula vs nasal mask as nasal interface in preterm neonates with respiratory distress â?? a noninferiority trial.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053155
Enrollment
80
Registered
2023-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: RAM CANNULA (Neotech): The RAM cannula (Neotech, Valencia, CA) is approved by the Food and Drug Administration as a Class I medical device for providing supplemental oxygen with 60â??80

Sponsors

Madhukar Rainbow Children Hospital New Delhi
Lead Sponsor
Dr Anil Batra
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates delivered between 30 to 36 weeks and 6 days of gestation admitted in NICU at Madhukar Rainbow childrenâ??s Hospital, New Delhi with respiratory distress within first 6 hours of life requiring the use of nCPAP during the study period.

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations. Neonates with shock requiring inotropes. We will also exclude neonates requiring mechanical ventilation at admission to NICU, those with poor respiratory efforts or apnea, worsening shock, pulmonary haemorrhage, parents not giving consent.

Design outcomes

Primary

MeasureTime frame
To compare the use of Ram cannula vs Nasal mask on the duration of nCPAP in preterm neonates born at gestational age of 30 weeks to 36 weeks and 6days with respiratory distress.Timepoint: 0-28 days

Secondary

MeasureTime frame
(1)Need for mechanical ventilation/ intubation within 72 hours of nCPAP initiation. (2)Nasal injury (3)the Incidence of bronchopulmonary dysplasia (BPD) (4)Intraventricular hemorrhage (â?¥grade2); (5)Periventricular Leukomalacia (PVL) (6)Pneumothorax; (7)Surfactant use following randomization. (8)Retinopathy of Prematurity (9)HsPDA (10)Time to reach full feeds (11)Mortality; Timepoint: 0-28 days

Countries

India

Contacts

Public ContactDr Rohan Yadav

Madhukar Rainbow Children Hospital, New Delhi

Drbatra77@gmail.com9650015236

Outcome results

None listed

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