Congential Absence of Heart StructureINSPIRE-CHDNCT03690245
Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease
A study testing Initiation of Resuscitation While Attached to the Cord in people with Congential Absence of Heart Structure and Congenital Malformation of Heart, Unspecified, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 20 minutes
- Conditions the study is for
- Congential Absence of Heart Structure, Congenital Malformation of Heart, Unspecified, Hypoplastic Left Heart Syndrome
- What is being tested?
- Initiation of Resuscitation While Attached to the Cord
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with rights or left heart congenital malformation
Who cannot join
- Infants with no heart congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease - INSPIRE-CHD
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.
Read more
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.
Read the 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:
- 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.
- 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:
- Infants randomized to resuscitative care for 120 seconds.
- 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.
- Conditions
- Congential Absence of Heart Structure, Congenital Malformation of Heart, Unspecified, Hypoplastic Left Heart Syndrome, TGA - Transposition of Great Arteries, Hypoplastic Right Heart Syndrome, Congential Malformations of Aortic Valve
- Being tested
- Initiation of Resuscitation While Attached to the Cord
- Keywords
- Congenital Heart Defect, Newborn
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of Resuscitation While Attached to the CordProcedure or surgery
Infants will receive active resuscitative care according to the Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning, oxygen, and respiratory support using iNSPiRE platform for 120 seconds while attached to the cord.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Infants will have immediate cord clamping and respiratory support afterwards Receives: Procedure: Initiation of Resuscitation While Attached to the Cord |
| Initiation of Resuscitation While Attached to the Cord | Experimental | Infants will receive respiratory support for 120 seconds while attached to the cord. Receives: Procedure: Initiation of Resuscitation While Attached to the Cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in heart rate
Measured: At 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start18 Dec 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congential Absence of Heart StructureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690245
- Sponsor's protocol ID
- Pro00069732
- Acronym
- INSPIRE-CHD
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease - INSPIRE-CHD
- ClinicalTrials.gov ID
- NCT03690245
- Acronym / sponsor ID
- INSPIRE-CHD / Pro00069732
- Conditions
- Congential Absence of Heart Structure, Congenital Malformation of Heart, Unspecified, Hypoplastic Left Heart Syndrome, TGA - Transposition of Great Arteries, Hypoplastic Right Heart Syndrome, Congential Malformations of Aortic Valve
- Keywords
- Congenital Heart Defect, Newborn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Infants randomized to resuscitative care for 120 seconds.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Initiation of Resuscitation While Attached to the CordInfants will have immediate cord clamping and respiratory support afterwards |
| Initiation of Resuscitation While Attached to the Cord | Experimental | Procedure: Initiation of Resuscitation While Attached to the CordInfants will receive respiratory support for 120 seconds while attached to the cord. |
Who may qualify
- Ages
- Up to 20 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with rights or left heart congenital malformation
Key exclusion criteria (1 listed)
- Infants with no heart congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initiation of Resuscitation While Attached to the CordInfants will receive active resuscitative care according to the Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning, oxygen, and respiratory support using iNSPiRE platform for 120 seconds while attached to the cord. | Procedure or surgery | Control, Initiation of Resuscitation While Attached to the Cord |
Primary outcome
Increase in heart rate
Time frame: At 5 minutes after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initiation of Resuscitation While Attached to the Cord in people with Congential Absence of Heart Structure and Congenital Malformation of Heart, Unspecified, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in heart rate (time frame: At 5 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.