Clinical trial NCT01861795: Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
Official title: An Oligo-center Observational Study to Collect Data in Preterm Neonates Born at or Above 27+0 Weeks of Gestational Age Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-invasive Ventilatory Support
Infant Respiratory Distress Syndrome
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 27
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm neonates on non-invasive ventilatory support in a hospital setting.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0
Secondary outcomes:
measure: Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96%
timeFrame: 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
measure: Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours
timeFrame: T0 to 98 hours
measure: Percentage of participants requiring instillation of an approved surfactant preparation
timeFrame: Gestational week (GW) 36+6 days
measure: Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36
timeFrame: Gestational Week 36
measure: Respiratory rate over time
timeFrame: T0 to Gestational Week 36
measure: Percentage of participants with a positive room-air challenge test at Gestational Week 36
timeFrame: Gestational Week 36
measure: Mortality rate
timeFrame: T0 to Gestational Week 36+6 days
measure: Time under Continuous Positive Airway Pressure ventilatory support
timeFrame: T0 to Gestational Week 36+6 days
measure: Time of additional oxygen demand (FiO2 > 21%)
timeFrame: T0 to Gestational Week 36+6 days
measure: Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU)
timeFrame: T0 to Gestational Week 36+6 days
measure: Time of intubation for mechanical ventilation
timeFrame: T0 to Gestational Week 36+6 days
measure: Time on any ventilation support
timeFrame: T0 to Gestational Week 36+6 days
measure: Days in hospital
timeFrame: From T0 to Gestational Week 36+6 days
Other outcomes:
Locations:
city: Hannover
country: Germany
city: Lübeck
country: Germany
city: Nuremberg
country: Germany
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: