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Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

Primary Purpose

Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
RFM (device) Visible
Sponsored by
Manuel Sanchez Luna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Premature focused on measuring Premature, Respiratory Function Monitor

Eligibility Criteria

undefined - 1 Minute (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.

Exclusion Criteria:

  • Congenital Malformations or Chromosomal Aberrations
  • Less Than 22 Weeks
  • Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
  • Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph<7.00)
  • reanimation unrecorded with video
  • no obtained informed consent

Sites / Locations

  • HGU Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RFM Visible

RFM No Visible

Arm Description

Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe.

Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks

Outcomes

Primary Outcome Measures

Reduce the need for surfactant.
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.

Secondary Outcome Measures

Need for intubation and intermittent mechanical ventilation (iMV)
Avoid intubation and Invasive Mechanical Ventilation in the next three days.
Incidence of dysplasia bronchopulmonary
Reduce incidence of dysplasia bronchopulmonary
CPAP on admission to NICU
Number of newborn with CPAP on admission to NICU
Incidence of mortality
Measure and get desired tidal volume to optimize resuscitation
Number of leaks and obstruction during ventilation mask
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce number of leaks and obstruction during mask ventilation and improves and set the desired tidal volume to optimize resuscitation.

Full Information

First Posted
April 4, 2016
Last Updated
April 21, 2016
Sponsor
Manuel Sanchez Luna
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1. Study Identification

Unique Protocol Identification Number
NCT02748720
Brief Title
Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
Official Title
Impact of Measurement of Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel Sanchez Luna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.
Detailed Description
HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life. EVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications. Patients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature
Keywords
Premature, Respiratory Function Monitor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFM Visible
Arm Type
Experimental
Arm Description
Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe.
Arm Title
RFM No Visible
Arm Type
No Intervention
Arm Description
Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks
Intervention Type
Other
Intervention Name(s)
RFM (device) Visible
Intervention Description
Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume
Primary Outcome Measure Information:
Title
Reduce the need for surfactant.
Description
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.
Time Frame
through study completion, an average of 3 days
Secondary Outcome Measure Information:
Title
Need for intubation and intermittent mechanical ventilation (iMV)
Description
Avoid intubation and Invasive Mechanical Ventilation in the next three days.
Time Frame
through study completion, an average of 3 days
Title
Incidence of dysplasia bronchopulmonary
Description
Reduce incidence of dysplasia bronchopulmonary
Time Frame
through study completion, an average of 1 year
Title
CPAP on admission to NICU
Description
Number of newborn with CPAP on admission to NICU
Time Frame
through study completion, an average of 1 day
Title
Incidence of mortality
Time Frame
through study completion, an average of 1 year
Title
Measure and get desired tidal volume to optimize resuscitation
Time Frame
through study completion, an average of 1 year
Title
Number of leaks and obstruction during ventilation mask
Description
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce number of leaks and obstruction during mask ventilation and improves and set the desired tidal volume to optimize resuscitation.
Time Frame
through study completion, an average of 1 day

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room. Exclusion Criteria: Congenital Malformations or Chromosomal Aberrations Less Than 22 Weeks Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph<7.00) reanimation unrecorded with video no obtained informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Zeballos, MD
Organizational Affiliation
Gregorio Marañón Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HGU Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

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