Feasibility of Uninterrupted Infant Respiratory Support Treatment

NCT04244890 | Completed

• 1 other identifier: 2019-05581
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility study of a simplified respiratory support system for newborn infants

Conditions

Respiratory Distress Syndrome, Newborn; Infant, Newborn; Respiratory Insufficiency Syndrome of Newborn

Keywords

Continuous Positive Airway Pressure; Resuscitation

Outcome Measures

Primary Outcomes (3)

• Number of interruptions in CPAP treatment

  Number of CPAP-support interruptions (n)

  0-240 minutes

• Duration of interruptions in CPAP treatment

  Duration CPAP support interruptions (min)

  0-240 minutes

• Cause of each interruption in CPAP treatment

  Reported reason for interruptions in CPAP treatment (free text as reported by staff)

  0-240 minutes

Secondary Outcomes (8)

• Ease of use: Respiratory support system set up

  0-10 minutes

• Ease of use: Airway and respiratory supportmanagement

  0-60 minutes

• Ease of use: Fixation and transport

  0-60 minutes

• Level of respiratory support

  0-240 minutes

• Response to respiratory support

  0-240 minutes

Study Arms (1)

Uninterrupted CPAP

Newborn infants in need of respiratory support directly after birth

Device: Uninterrupted CPAP for the first hours of life

Interventions

Uninterrupted CPAP for the first hours of life DEVICE

Directly at birth the infant will be supported with PPV with PEEP as needed, followed by nasal CPAP. Support will be provided with a single device for up to four hours.

Uninterrupted CPAP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital, Neonatology department

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• Baldursdottir S, Gunnarsdottir K, Donaldsson S, Jonsson B, Drevhammar T. Skin-to-skin stabilisation and uninterrupted respiratory support for preterm infants after birth: feasibility of a new and simplified rPAP system. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):638-642. doi: 10.1136/archdischild-2023-326409.

  PMID: 38514168 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Drevhammar, PhD

  meaning.....

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, PhD

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 28, 2020
• Study Start: February 21, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

SE (1)