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Trial record 1 of 1 for:    NCT01861795
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Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01861795
First Posted: May 24, 2013
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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.

Condition Intervention
Non-invasive Ventilatory Support Infant Respiratory Distress Syndrome Other: Preterm Neonates

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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).

  • 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 [ 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).

  • Respiratory rate over time [ Time Frame: T0 to Gestational Week 36 ]
  • 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.

  • Mortality rate [ Time Frame: T0 to Gestational Week 36+6 days ]
  • Time under Continuous Positive Airway Pressure ventilatory support [ Time Frame: T0 to Gestational Week 36+6 days ]
  • Time of additional oxygen demand (FiO2 > 21%) [ Time Frame: T0 to Gestational Week 36+6 days ]
  • Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU) [ Time Frame: T0 to Gestational Week 36+6 days ]
  • Time of intubation for mechanical ventilation [ Time Frame: T0 to Gestational Week 36+6 days ]
  • 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.

  • Days in hospital [ Time Frame: From T0 to Gestational Week 36+6 days ]

Estimated Enrollment: 40
Study Start Date: June 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Preterm Neonates

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   27 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm neonates on non-invasive ventilatory support in a hospital setting.
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861795


Locations
Germany
Hannover, Germany
Lübeck, Germany
Nuremberg, Germany
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01861795     History of Changes
Other Study ID Numbers: RS-7261-201-RD
U1111-1141-9396 ( Registry Identifier: WHO )
First Submitted: April 26, 2013
First Posted: May 24, 2013
Last Update Posted: August 22, 2014
Last Verified: August 2014

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases