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

NCT ID: NCT02748720

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Infant, Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

RFM Visible

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.

Group Type: EXPERIMENTAL

RFM (device) Visible

Intervention Type: OTHER

Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume

RFM No Visible

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RFM (device) Visible

Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume

Intervention Type: OTHER

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

• Maximum Eligible Age: 1 Minute
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manuel Sanchez Luna

OTHER

Sponsor Role: lead

Responsible Party

Manuel Sanchez Luna

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gonzalo Zeballos, MD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Locations

HGU Gregorio Marañón

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

2014-05

Identifier Type: -

Identifier Source: org_study_id