Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

NCT05399914 | Completed

• 1 other identifier: 310/2021BO1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

Conditions

Preterm Infant; Delivery Room; Respiratory Support; Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV)

Outcome Measures

Primary Outcomes (1)

• Synchronisation rate

  Synchronisation rate (sensitivity/true positive rate) of S-NIPPV in the delivery room meaning the proportion of graseby triggered synchronized ventilator breaths with corresponding RIP signal related to all spontaneous breaths detected by RIP.

  First 10 minutes after birth

Secondary Outcomes (21)

• False negative rate

  First 10 minutes after birth

• False positive rate

  First 10 minutes after birth

• Proportion of artifacts

  First 10 minutes after birth

• Specificity (true negative rate)

  First 10 minutes after birth

• Proportion of back up breaths

  First 10 minutes after birth

Study Arms (1)

Preterm infants with a gestational age (GA) between 26 ≥ and < 32 weeks

Other: S-NIPPV

Interventions

S-NIPPV OTHER

Synchronized noninvasive positive pressure ventilation during the first 10 minutes after birth.

Preterm infants with a gestational age (GA) between 26 ≥ and < 32 weeks

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born at University Hospital in Tübingen.

You may qualify if:

• Preterm infants with a gestational age (GA) between 26 ≥ and \< 32 weeks

You may not qualify if:

• Major congenital malformations
• Refused parental consent (prenatal parental consent is necessary)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• Warth PP, Ruegger CM, Gaertner VD, Braun W, Molnar K, Brozek J, Poets CF, Springer L. Synchronised Non-Invasive Intermittent Positive Pressure Ventilation in Very Preterm Infants After Birth: A Feasibility Study. Acta Paediatr. 2025 Dec;114(12):3159-3165. doi: 10.1111/apa.70220. Epub 2025 Jul 16.

  PMID: 40665887 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: June 1, 2022
• Study Start: April 22, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: September 23, 2024

Record last verified: 2022-04

Locations

DE (1)