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

Takeda

Status: Completed

Conditions: Infant Respiratory Distress Syndrome; Non-invasive Ventilatory Support

Treatments: Other: Preterm Neonates

Study type: Observational

Funder types: Industry

Identifiers

NCT01861795

RS-7261-201-RD

U1111-1141-9396 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 27 to 36 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Preterm Neonates

Description:

Preterm neonates born at or above 27+0 weeks of gestational age sufficiently stable on nasal continuous positive airway pressure (CPAP) will be treated by standard of care.

Treatment:

Other: Preterm Neonates