Congenital Diaphragmatic HerniaINSPIRE-CDHNCT03094039
Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia
A study testing Ventilatory support while attached to the cord and Immediate cord clamping in people with Congenital Diaphragmatic Hernia, run by University of Alberta at 1 site in Canada.
Trial summary
This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). Read more about this study
- Who is it for?
- Ages Up to 10 minutes
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Ventilatory support while attached to the cord and Immediate cord clamping
- 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
- 27 Apr 2017to 31 Aug 2019
- 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 10 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn infants with an antenatal diagnosed CDH.
Who cannot join
- Severe antepartum or postpartum hemorrhage.
- Any obstetrical concern.
- Lack of parental consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants.
Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation.
With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Ventilatory support while attached to the cord, Immediate cord clamping
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilatory support while attached to the cordProcedure or surgery
Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care.
Immediate cord clampingProcedure or surgery
Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.
| Study group | Role | What they receive |
|---|---|---|
| Ventilatory support while attached to the cord | Experimental | Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care. Receives: Procedure: Ventilatory support while attached to the cord |
| Immediate cord clamping | Active comparator | Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol. Receives: Procedure: Immediate cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants with hypotension requiring inotropes
Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit.
Measured: first 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start27 Apr 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Why it stopped: no patient available for 18 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094039
- Sponsor's protocol ID
- Pro00069729
- Acronym
- INSPIRE-CDH
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2017
- Last updated
- 3 Oct 2019
- 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 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT03094039
- Acronym / sponsor ID
- INSPIRE-CDH / Pro00069729
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient available for 18 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 29 Mar 2017 (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.
This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants.
Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation.
With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilatory support while attached to the cord | Experimental | Procedure: Ventilatory support while attached to the cordInfants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care. |
| Immediate cord clamping | Active comparator | Procedure: Immediate cord clampingInfants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol. |
Who may qualify
- Ages
- Up to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn infants with an antenatal diagnosed CDH.
Key exclusion criteria (3 listed)
- Severe antepartum or postpartum hemorrhage.
- Any obstetrical concern.
- Lack of parental consent.
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 |
|---|---|---|
| Ventilatory support while attached to the cordInfants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care. | Procedure or surgery | Ventilatory support while attached to the cord |
| Immediate cord clampingInfants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol. | Procedure or surgery | Immediate cord clamping |
Primary outcome
Proportion of infants with hypotension requiring inotropes
Time frame: first 24 hours after birth
Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit.
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 3 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
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Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
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Recruiting
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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RecruitingObservational study
Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science
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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.
Georg Schmolzer principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilatory support while attached to the cord and Immediate cord clamping in people with Congenital Diaphragmatic Hernia, 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 3 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 3 Oct 2019. 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?
Proportion of infants with hypotension requiring inotropes (time frame: first 24 hours 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 3 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.