Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease

Related Clinical Trial
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels Comprehensive Long-term Follow up of Adults With Arterial Switch Operation Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease Canadian Adult Congenital Heart Disease Intervention Registry Physical Training in Transposition of the Great Arteries Eplerenone in Systemic Right Ventricle N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) Genetic Determinants of Congenital Heart Disease Outcomes Myocardial Contrast Echocardiography in Congenital Heart Disease Sudden Cardiac Death in Systemic Right Ventricle Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease Comparison of Hematocrit Levels in Infant Heart Surgery Late Function After Surgery for Transposition of the Great Arteries Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA) MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries Fibrosis, Valvular and Ventricular Function in Patients With TGA Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults Nitric Oxide During Bypass for Arterial Switch Operation

Brief Title

Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease

Official Title

Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease - INSPIRE-CHD

Brief Summary

      Before birth, the placenta (a structure with many blood vessels attached to the inside of
      your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are
      sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby.
      After a baby is born the cord is clamped and babies have to start breathing and support
      themselves.

      At the moment when a baby with congenital heart disease is born they will have their cord
      clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical
      team will start to help a baby transition by carefully monitoring their oxygen saturation
      (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have
      shown that clamping the cord right after birth might causes the baby to miss the benefits of
      receiving blood from the umbilical cord / placenta.

      Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time.
      Studies show that DCC has many benefits especially for a newborn baby, such as higher iron
      storage, less need for blood transfusions, and improved circulation. This can be done while
      the baby is breathing on its own or while we help you baby breath (this is called
      resuscitation).

      This study aims to examine whether DCC while providing resuscitation in infants with CHD is
      helpful compared to immediate cord clamping.

      Prior to the birth of your baby, a sealed envelope will be opened and your baby will be
      randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will
      be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be
      clamped after 120 seconds during which time your baby will receive the care he/she requires
      by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she
      will be brought over the resuscitation bed to be cared for by the same team.
    

Detailed Description

      Purpose: Do respiratory and cardiovascular function parameters differ in infants with
      congenital left heart heart disease (CHD) who receive active resuscitative care during
      Delayed Cord Clamping (DCC) compared to immediate cord clamping (ICC)?

      Hypothesis: Infants with left heart CHD who receive active resuscitative care during DCC will
      have improved heart rate in the delivery room (DR) compared to those who receive ICC.

      Justification: Based on our literature review, this is the first study to assess the effect
      of initiating resuscitation during DCC on cardiovascular function in newborn infants with
      left heart CHD. We speculate that initiating resuscitation during DCC will lead to a smoother
      transition with improving respiratory and cardiovascular stability in these infants. The
      results of our study will than be used to organise a large-multi-center trial.

      Objectives: infants with left heart CHD who receive active resuscitative care during DCC will
      have improved heart rate in the delivery room (DR) compared to those who receive ICC.

      Research Method/Procedures:

      Study design: Randomized controlled trial.

      Study population: All infants with left heart CHD born at Royal Alexandra Hospital are
      eligible for the study.

      Intervention: Infants will be randomized to one of the following study arms:

        1. Intervention group: Infants will receive active resuscitative care according to the
           Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning,
           oxygen, and continuous positive airway pressure (CPAP) or PPV using iNSPiRE platform for
           120 seconds during DCC.

        2. Control group: Infants will have immediate cord clamping as per clinical routine.

      Study protocol: Randomization: The unique trial number will be block randomized and computer
      generated.

      Allocation Concealment: Sealed Envelope will be provided. The sealed envelopes will contain a
      folded card box, which allocates the unique trial number for this infant and the label "DCC
      group" or "ICC group".

      Blinding: There will be no blinding, as it would not be feasible to conduct resuscitation
      without the resuscitation team knowing the actual intervention that the subject will receive.

      Intervention group: The infant will be placed on iNSPiRE platform, the airway will be cleared
      if necessary; the baby will be dried and stimulated, and pulse oximeter will be placed on the
      right wrist. CPAP will be administered using T-piece resuscitator at 6 cmH2O, with FiO2 of
      21%. PPV will be provided at an initial peak inspiratory pressure (PIP) of 24 cmH2O and rate
      of 40-60 bpm in case of apnea, gasping breathing or heart rate <100 bpm. Interventions will
      be recorded at 10 seconds intervals; while vital signs will be recorded at 30 seconds
      intervals. At 120 seconds after birth, the cord will be clamped and the platform will be
      wheeled to the radiant warmer in the delivery room, the baby will be transferred on CPAP, and
      resuscitation/transitional care will continue according to the institutional guidelines. If
      immediate intubation or chest compressions are required despite initiating CPAP or PPV via
      mask and T-piece resuscitator, the procedure will be interrupted, the cord will be clamped,
      and the baby transferred to the radiant warmer.

      Control group: Infants randomized to the control arm will have immediate cord clamping as per
      hospital guidelines. Once on the radiant warmer, airway will be cleared, and pulse oximeter
      placed on the right wrist and routine resuscitation care as per hospital guidelines.

      Management in the delivery room on the radiant warmer for all study groups: The subsequent
      management of the infant in the delivery room will follow the institutional guidelines. In
      addition, we will use Philips NM3 Respiratory Function Monitor (RFM), placed on a special
      trolley/platform to measure the delivered airway pressures, tidal volume (VT), and ECO2 using
      a flow sensor placed between the face mask (or the endotracheal tube in case of intubated
      infant) and the T-piece resuscitator. The pulse oximeter sensor will be connected to the RFM.
      The RFM display screen will show only the SpO2, and other parameters will be concealed from
      the resuscitation team. The RFM will be connected to a laptop to allow real time data
      acquisition. A video camera mounted on the top of the radiant warmer will be used to record
      the management and will stream to the same laptop. Axillary temperature will be measured once
      the infant is transferred to the radiant warmer and at 10 minutes of age. Once the infant is
      stable he/she will be transferred to the NICU.

      Management in the NICU: Infants will be managed according to the institutional guidelines.
      Neonatal Echocardiography will be performed at 6 and 24 hours of age to assess cardiac
      function.

      Plan for data analysis:

      Pregnancies complicated by fetal left heart CHD will be recruited through the Fetal &
      Neonatal Cardiology Program at the Royal Alexandra Hospital over a period of 24 months.
      Approximately another three months will be required to collect hospital data on all infants
      enrolled. Resuscitation data will be collected on a standard form (Neonatal Resuscitation
      Record) that will form part of each infant's hospital record. Other medical data on each
      infant will be collected on Case Report Forms and hemodynamic data will be generated in the
      first 24 hours as part of the routine care of these infants on the David Schiff NICU.

      The signals of airway flow, tidal volume, airway pressure, and exhaled CO2 will be recorded
      at 200Hz using Spectra physiological recording program (a customized neonatal respiratory
      physiology program). A breath-by-breath analysis will be performed manually for the duration
      of each recording. Tidal volume, inflation time, gas flow and exhaled CO2 will be measured.

      Descriptive statistics will be used to describe the population. We will use student t-test,
      Mann Whitney U test for continuous variables and Chi square test or Fisher Exact Test for
      categorical variables to compare the groups as appropriate. Randomized infants will be
      analyzed in their respective groups regardless of the actual intervention received following
      the intension-to-treat concept. However, a priori subgroup comparison will be performed
      between the following groups:

        1. Infants randomized to resuscitative care for 120 seconds.

        2. Infants randomized to the control group.

      Sample size: This is a feasibility trial and we estimate to recruit 40 infants (20 per group)
      to assess feasibility of this approach.
    


Study Type

Interventional


Primary Outcome

Increase in heart rate


Condition

Congential Absence of Heart Structure

Intervention

Initiation of Resuscitation While Attached to the Cord

Study Arms / Comparison Groups

 Control
Description:  Infants will have immediate cord clamping and respiratory support afterwards

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

December 18, 2018

Completion Date

December 31, 2020

Primary Completion Date

August 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Infants with rights or left heart congenital malformation

        Exclusion Criteria:

          -  Infants with no heart congenital malformation
      

Gender

All

Ages

N/A - 20 Minutes

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03690245

Organization ID

Pro00069732


Responsible Party

Sponsor

Study Sponsor

University of Alberta


Study Sponsor

, , 


Verification Date

February 2020