Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks)

NCT02958488 | Completed

• 1 other identifier: 9606
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS). The secondary objective is to evaluate the safety of HFNC in this indication.

Conditions

Respiratory Distress Syndrom; High Flow Nasal Cannula

Keywords

34 to 36 Weeks Preterm Neonates; Respiratory Distress Syndrom; High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

• Total duration of noninvasive ventilation

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

Secondary Outcomes (5)

• Rate of hospitalization in NICU for RDS

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

• Rate of RDS aggravation

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

• Rate of intubation

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

• Rate of good tolerance of LNHD technique

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

• Incidence of side effects, including pain and discomfort, skin lesions, abdominal distension, air leak syndrome, necrotizing enterocolitis, hypothermia, hypoglycemia

  from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

Study Arms (1)

Preterm Neonates with Respiratory Distress Syndrome

EXPERIMENTAL

34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome

Device: High Flow Nasal Cannula

Interventions

High Flow Nasal Cannula DEVICE

Preterm Neonates with Respiratory Distress Syndrome

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn premature between 34 and 36 weeks of gestational age
• Moderate RDS after 30 minutes of life while treated with + 5cm H2O positive airway pressure
• Presence of a dedicated pediatric nurse and pediatrician
• Parental consent

You may not qualify if:

• Need for early intubation
• Severe RDS, defined by one of the following: Silverman-Anderson score \> 6, severe hypoxia (FiO2 \> 0.5), hemodynamic disorders (HR\> 180 / min, MABP \<30mmHg, capillary refill time \> 5s, pallor), and severe apneas (\> 5s and / or with bradycardia \<80 /min)
• minute Apgar score \< 3 and / or five minutes Apgar score \< 7
• Birth weight \< 1800g and / or IUGR \<-2 SD
• Congenital heart, pulmonary, facial, or digestive malformation
• Subject not affiliated to social security system
• Legal representatives unable to understand the terms of the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

Study Officials

• Gilles Cambonie, Professor

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: November 8, 2016
• Study Start: March 16, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 25, 2020
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

FR (1)