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Completed

NCT Number: NCT01861795

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

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.

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Key information

Conditions

Non-invasive Ventilatory Support Infant Respiratory Distress Syndrome Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

27 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanover, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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.

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).
  • 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.

Treatment and study plan

Preterm Neonates

Other

Preterm Neonates

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)

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

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

Secondary outcomes

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

    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

    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.

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

    Time frame: 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).

  3. Percentage of participants requiring instillation of an approved surfactant preparation

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

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

    Time frame: Gestational Week 36

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

  5. Respiratory rate over time

    Time frame: T0 to Gestational Week 36

  6. Percentage of participants with a positive room-air challenge test at Gestational Week 36

    Time frame: Gestational Week 36

    The room-air challenge test is defined as a weaning attempt allowing the participant to breath non-pressurized room air for 30 minutes. If a blood oxygen saturation of ≥90% is achieved during weaning, the weaning was successful and patients are considered to be free of bronchopulmonary dysplasia and need no further ventilation support.

  7. Mortality rate

    Time frame: T0 to Gestational Week 36+6 days

  8. Time under Continuous Positive Airway Pressure ventilatory support

    Time frame: T0 to Gestational Week 36+6 days

  9. Time of additional oxygen demand (FiO2 > 21%)

    Time frame: T0 to Gestational Week 36+6 days

  10. Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU)

    Time frame: T0 to Gestational Week 36+6 days

  11. Time of intubation for mechanical ventilation

    Time frame: T0 to Gestational Week 36+6 days

  12. Time on any ventilation support

    Time frame: T0 to Gestational Week 36+6 days

    Any ventilation support includes continuous positive airway pressure (CPAP), manual support and intubation.

  13. Days in hospital

    Time frame: From T0 to Gestational Week 36+6 days

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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