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

NCT01861795 | Completed

• 2 other identifiers: RS-7261-201-RDU1111-1141-9396
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-invasive Ventilatory Support; Infant Respiratory Distress Syndrome

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (13)

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

  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

  T0 to 98 hours

• Percentage of participants requiring instillation of an approved surfactant preparation

  Gestational week (GW) 36+6 days

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

  Gestational Week 36

• Respiratory rate over time

  T0 to Gestational Week 36

Study Arms (1)

Preterm Neonates

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.

Other: Preterm Neonates

Interventions

Preterm Neonates OTHER

Preterm Neonates

Preterm Neonates

Eligibility Criteria

• Age: 27 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates on non-invasive ventilatory support in a hospital setting.

You may qualify if:

• \. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).
• \. 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.
• \. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.
• \. 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.

You may not qualify if:

• \. 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).
• \. 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.
• \. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Lübeck, Germany

Location

Unknown Facility

Nuremberg, Germany

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 24, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

DE (3)