Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support

Takeda40 enrolled

Overview

The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.

The objective of this study is to collect data on vital signs, oxygen requirements and other data in preterm infants who are breathing stably on non-invasive ventilatory support. The data obtained during this study will be used to compare data obtained in a future study that will add a new medicinal product in combination with non-invasive ventilatory support to accelerate lung development in preterm infants. The study will enroll approximately 40 patients. Participants will not be receiving any investigational medicinal product or device in this study. All participants will have vital signs, oxygen requirements and other data collected continuously throughout the study. This multi-centre trial will be conducted in Germany. The overall time to participate in this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of gestational age or until they are discharged from the hospital.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-invasive Ventilatory Support Infant Respiratory Distress Syndrome

Interventions

Preterm NeonatesOTHER

Preterm Neonates

Eligibility

Sex: ALLMin age: 27 WeeksMax age: 36 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery). 2\. Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW. 3\. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g. 4\. CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O. 5. Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0. Exclusion Criteria: * 1\. FiO2 \> 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0). 2\. Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study. 3\. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.

Locations (3)

Unnamed facility

Hanover, Germany

Unnamed facility

Lübeck, Germany

Unnamed facility

Nuremberg, Germany

Outcomes

Primary Outcomes

Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2)

Fraction of inspired oxygen (FiO2) is the amount of oxygen in the ventilator outlet gas flow.

Time frame: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0

Secondary Outcomes

Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96%

Saturation of peripheral oxygen is the amount of oxygen bound to hemoglobin in the blood expressed as a percentage of the maximal binding capacity. It will be measured with a pulse oximeter.

Time frame: T0 and at 0.25, 0.5, 0.75 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 4, 4.25. 4.5, 4.74, 5, 5.25, 5.75, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 hours

Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours

CPAP failure is reached when FiO2 ≥ 50% is need for more than 15 minutes to reach 90% saturation of peripheral oxygen (SpO2).

Time frame: T0 to 98 hours

Percentage of participants requiring instillation of an approved surfactant preparation

Time frame: Gestational week (GW) 36+6 days

Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36

Bronchopulmonary dysplasia (BPD) is defined as a lung injury in preterm neonates resulting from oxygen toxicity and/or mechanical ventilation (elevated air pressure).

Time frame: Gestational Week 36

Respiratory rate over time

Time frame: T0 to Gestational Week 36

Data from ClinicalTrials.gov

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