Clinical trial NCT02748720: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Premature
Respiratory Function Monitor
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 126
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Reduce the need for surfactant.
timeFrame: through study completion, an average of 3 days
Secondary outcomes:
measure: Need for intubation and intermittent mechanical ventilation (iMV)
timeFrame: through study completion, an average of 3 days
measure: Incidence of dysplasia bronchopulmonary
timeFrame: through study completion, an average of 1 year
measure: CPAP on admission to NICU
timeFrame: through study completion, an average of 1 day
measure: Incidence of mortality
timeFrame: through study completion, an average of 1 year
measure: Measure and get desired tidal volume to optimize resuscitation
timeFrame: through study completion, an average of 1 year
measure: Number of leaks and obstruction during ventilation mask
timeFrame: through study completion, an average of 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HGU Gregorio Marañón
Study officials:
affiliation: Gregorio Marañón Hospital
name: Gonzalo Zeballos, MD
role: PRINCIPAL_INVESTIGATOR
References: