Feasibility of Uninterrupted Infant Respiratory Support Treatment

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

Feasibility study of a simplified respiratory support system for newborn infants

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.

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