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

NCT ID: NCT05399914

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2023-10-11

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.

Detailed Description

The study period will be the first 10 minutes after birth.

All patients will be non-invasively ventilated using an EVE NEO ventilator (CE 0482, Fritz Stephan GmbH, Gackenbach, Germany). A facemask will be used throughout the study period. Synchronization will be achieved using graseby capsule (Stephan, Vio Healthcare), which will be secured at the abdominal wall on the midaxillary line below the ribs. For the detection of spontaneous breaths respiratory induction plethysmography (RIP) is used. For this purpose, an extra small plethysmography belt (Sleepsense, Elgin, USA) is placed around the abdomen. The data of the plethysmography belts are processed and stored with the NewLifebox-XL (Advanced Life Diagnostics UG, Weener, Germany) and merged with the data from the ventilator for later evaluation.

Infants according to the clinician's assessment only needing CPAP will receive S-NIPPV with very low PIP levels. This enables to have enough ventilator breaths applied for analysis to obtain sufficient data about the synchronization rate of S-NIPPV in the delivery room and meanwhile consider the infant's safety by not applying high pressures where it might not be needed. The ventilator support settings will be PIP 10, PEEP 6 in the noninvasive pressure controlled assist control ventilation (nPC-ACV+) mode. In this mode every spontaneous breath is supported by a ventilator breath (if the triggering level is exceeded). The triggering level will be set at 0,5 to avoid autotriggering and unsupported breaths. The inspiratory time will be set at max. 0,3 sec. The backup ventilation rate is set at 60 per minute.The EVE NEO ventilator has in the nPC-ACV+ mode an option where the ventilator breaths are interrupted/stopped as soon as the graseby capsule detects a start of spontaneous expiration.

If the infant according to the clinician's assessment needs S-NIPPV (e.g. the infant is apnoeic, and/or heart rate is below 100 bpm), the pressure of S-NIPPV will be augmented to target PIP 20, PEEP 6 (unless clinical concerns require an adjustment). The respiratory support can be deescalated to PIP 10 once the clinician deems the higher pressure no longer necessary.

The following demographical characteristics will be collected from the patient charts (pseudonymized): gender, gestational age, birth weight, antenatal steroids, mode of delivery, reason for prematurity (prolong premature rupture of membrane, infection, pathologic CTG, pathological doppler, gestosis), time of cord clamping, umbilical cord pH, FiO2 requirement, APGAR.

The following interventions within the first 10 minutes after birth including the time will be noted: tactile stimulation, placement of an intravenous line, non-invasive surfactant administration, intubation, chest compression, administration of volume, catecholamine, blood or other medication.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

S-NIPPV

Intervention Type: OTHER

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

Interventions

S-NIPPV

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

References

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 Jul 16. doi: 10.1111/apa.70220. Online ahead of print.

Reference Type: DERIVED

PMID: 40665887 (View on PubMed)

Other Identifiers

310/2021BO1

Identifier Type: -

Identifier Source: org_study_id