Skip to content

Can Heated Humidified High Flow Nasal Cannula (HHHFNC) replace Nasal CPAP (nCPAP) for respiratory support in preterm infants with respiratory distress

Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal continuous positive airway pressure (nCPAP) for respiratory support in preterm infants with respiratory distress: An Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006108
Enrollment
218
Registered
2015-08-19
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: null- Preterm infant with gestation more than 27 weeks and birth weight more than 999 grams and respiratory distress within the first 6 hours of birth.

Interventions

Intervention1: HHHFNC group: Nasal cannulas will be applied as per manufacturer suggestions with recommendations that the prong outer diameter would occupy than 50% of the nares internal diameter. Fr

Sponsors

Fernandez hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infant with gestation more than 29 weeks and birth weight more than 999 grams and respiratory distress within the first 6 hours of birth. Gestation assessed from the mothers LMP or from New Ballard score when LMP is unreliable or not available. Respiratory distress defined as presence of tachypnea, chest retraction and grunt (any of the two).

Exclusion criteria

Exclusion criteria: 1) Birth weight less than 1000 g 2) Gestational age less than28 weeks 3) Pneumothorax on Chest X-ray 4) Shock requiring inotropic support, multiorgan dysfunciton and encephalopathy 5) Abnormalities of upper and lower airways precluding use of CPAP or HHHFNC (Pierre-Robin, Treacher Collins, Goldenhar, choanal atresia, cleft lip/palate) 6) Serious abdominal, cardiac, or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, or diaphragmatic hernia

Design outcomes

Primary

MeasureTime frame
Failure of the support mode is the primary outcome of the study.Timepoint: 72 hours

Secondary

MeasureTime frame
Bronchopulmonory dysplasiaTimepoint: 36 weeks of gestation;duration of noninvasive ventilation (either nCPAP or HHHFNC)Timepoint: Discharge;Duration of oxygen therapyTimepoint: Discharge;Duration of ventilationTimepoint: Discharge;Grade of nasal injuryTimepoint: discharge;Intraventricular hemorrhageTimepoint: Discharge;MortalityTimepoint: Discharge;Necrotising enterocolitisTimepoint: Discharge;Need of mechanical ventilation in first 7 daysTimepoint: 8th day;need of mechanical ventilation in the first 72 hoursTimepoint: 72 hours;Patent ductus arteriosusTimepoint: Discharge;Periventricular leucomalciaTimepoint: 40 weeks of gestation;Pulmonary air leaksTimepoint: Discharge;Retinopathy of prematurityTimepoint: Discharge;Supplemental oxygen at 28 days of lifeTimepoint: 28 days of life

Countries

India

Contacts

Public ContactDr Srinivas Murki

Fernandez Hospital

srinivasmurki2001@gmail.com

Outcome results

None listed

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