Clinical trial NCT04244890: Feasibility of Uninterrupted Infant Respiratory Support Treatment
Official title: Feasibility of Respiratory Management of Infants Needing Positive Pressure Ventilation or CPAP, Using a Single System to Deliver Uninterrupted Support Directly at Birth and the First Hours of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Newborn
Infant, Newborn
Respiratory Insufficiency Syndrome of Newborn
Keywords: Continuous Positive Airway Pressure
Resuscitation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants in need of respiratory support directly after birth. Consent will be obtained from parents before delivery. Infants will be enrolled when investigators are available (convenience sample).

Brief summary: Feasibility study of a simplified respiratory support system for newborn infants

Detailed description: The study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. The study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system.

The system is a modified version of the commercially available rPAP system. The revised design has a simplified gas supply and allows elimination of a complicated driver. The new system has low resistance to breathing equal to the rPAP system. The study will recruit 40-60 infants in a single centre without a comparison arm.

The trial is conducted as a first step towards a large randomised trial.

Eligibility criteria: Inclusion Criteria:

* Vaginal delivery at gestational age between 28+0 and 34+6
* Caesarean section at gestational age between 28+0 and 37+6
* Infants in need of respiratory support in delivery-room

Exclusion Criteria:

* Carciac malformations
* Airway malformations
* Known syndromes or neuromuscular disorders
* Transfer to other hospital within 4 hours likely

Primary outcomes:
measure: Number of interruptions in CPAP treatment
timeFrame: 0-240 minutes
measure: Duration of interruptions in CPAP treatment
timeFrame: 0-240 minutes
measure: Cause of each interruption in CPAP treatment
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Ease of use: Respiratory support system set up
timeFrame: 0-10 minutes
measure: Ease of use: Airway and respiratory supportmanagement
timeFrame: 0-60 minutes
measure: Ease of use: Fixation and transport
timeFrame: 0-60 minutes
measure: Level of respiratory support
timeFrame: 0-240 minutes
measure: Response to respiratory support
timeFrame: 0-240 minutes
measure: Respiratory support at 48 hours
timeFrame: 0-240 minutes
measure: Rare events in clinical management
timeFrame: 0-240 minutes
measure: Adverse events and safety
timeFrame: 0-240 minutes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Neonatology department
Study officials:
affiliation: meaning.....
name: Thomas Drevhammar, PhD
role: STUDY_DIRECTOR
References: