An interventional study of DING in Congenital Diaphragmatic Hernia, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 1 Day to 1 Day. Per ClinicalTrials.gov, last updated 2020-01-21.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
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Among 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States — 24 open to participants now, 28 under way, 2 of them phase 3. Hernias, Diaphragmatic, Congenital · United States.
Among the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States, this one is the 18th largest by enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2017, is one of 28 with no phase, and was the 19th registered.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
Browse Hernias, Diaphragmatic, Congenital studies →24 of the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States are open now. Recruiting first, the newest first:
Mauro H. Schenone · Sites in United States
Ages 18–50 · Women only
Dr Erin Perrone · Sites in United States
Ages 18+
Vincent Duron · Sites in United States
Ages 18+
The University of Texas Health Science Center, Houston · Sites in United States
Ages 0 mo–1 mo
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18–50 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 32 Hernias, Diaphragmatic, Congenital studies recruiting now, 16 (50%) set no upper age limit and 16 (50%) stop at 75 or younger; 13 take children under 18; 6 take healthy volunteers.
This study: 1 Day to 1 Day · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Median enrollment 21 across the 36 interventional studies, 51 across the 8 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
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None of the 45 has an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 2 studies filed under Hernias, Diaphragmatic, Congenital — fewer than ten, so there is no comparison to draw.
2 of the studies in Hernias, Diaphragmatic, Congenital with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04583644Hanmin LeePilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) | 2027-04 |
| NCT00950118Columbia UniversityDiaphragmatic Hernia Research & Exploration, Advancing Molecular Science | 2027-09 |
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Among the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality and need for life-saving interventions such as extracorporeal membrane oxygenation (ECMO), nitric oxide, and vasopressor support. Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.
Infants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to DR resuscitation is immediate umbilical cord clamping (UCC) followed by intubation and mechanical ventilation. Animal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output. To date, this approach has not been studied in infants with CDH.
Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality (29%) and need for life-saving interventions such as ECMO (33%), nitric oxide (62%), and vasopressor support (73%).1 Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.
Infants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to delivery room (DR) resuscitation is immediate UCC followed by intubation and mechanical ventilation. The goals of this strategy are to immediately recruit and aerate the lung for gas exchange and oxygenation, while simultaneously avoiding gaseous distention of the thoracic gastrointestinal contents.
Animal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output.
The investigators hypothesize that a sequence of intubation, gentle ventilation, and then umbilical cord clamping will result in improved cardiovascular transition after birth in infants with CDH. To date, this approach has not been studied in infants with CDH. The DING trial will assess the feasibility and safety of this intervention in infants with CDH.
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Exclusion Criteria:
Delayed Cord Clamping
Procedure: DING
Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping
Infants who are intubated and have ventilation initiated prior to umbilical cord clamping
Time frame: 3 minutes of life
Mean Arterial Potential of Hydrogen (pH) in Arterial Blood
Arterial pH on first blood gas
Time frame: Approximately 1 hour of life
Mean Partial Pressure of O2 in Arterial Blood (PaO2)
Arterial PaO2 on first blood gas
Time frame: Approximately 1 hour of life
Oxygenation Index (OI)
Oxygenation index \[OI\] with first obtained blood gas
Time frame: First obtained blood gas
Proportion of Infants Who Require Vasopressors
Proportion of infants who require vasopressors in first 48 hours of life
Time frame: First 48 hours of life
Presence of Severe Pulmonary Hypertension
Presence of severe pulmonary hypertension on first echocardiogram
Time frame: Approximately 24 hours of life
Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment
Proportion of infants who require ECMO treatment in first 7 days of life
Time frame: 7 days of life
Mortality in First 7 Days of Life
Proportion of infants with mortality in the first 7 days of life
Time frame: First 7 days of life
| Milestone | DING Intervention |
|---|---|
| Started | 21 |
| Completed | 20 |
| Not completed | 1 |
| Withdrew: No longer eligible at time of delivery | 1 |
Infants who are intubated and have ventilation initiated prior to umbilical cord clamping
| Participants | DING Intervention |
|---|---|
| Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping | 17 |
Arterial pH on first blood gas
| pH | DING Intervention |
|---|---|
| Mean Arterial Potential of Hydrogen (pH) in Arterial Blood | 7.02 ± 0.15 |
Arterial PaO2 on first blood gas
| PaO2 | DING Intervention |
|---|---|
| Mean Partial Pressure of O2 in Arterial Blood (PaO2) | 47 (39 to 52) |
Oxygenation index \[OI\] with first obtained blood gas
| oxygenation index | DING Intervention |
|---|---|
| Oxygenation Index (OI) | 17.5 (12.8 to 25.5) |
Proportion of infants who require vasopressors in first 48 hours of life
| Participants | DING Intervention |
|---|---|
| Proportion of Infants Who Require Vasopressors | 13 |
Presence of severe pulmonary hypertension on first echocardiogram
| Participants | DING Intervention |
|---|---|
| Presence of Severe Pulmonary Hypertension | 12 |
Proportion of infants who require ECMO treatment in first 7 days of life
| Participants | DING Intervention |
|---|---|
| Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment | 7 |
Proportion of infants with mortality in the first 7 days of life
| Participants | DING Intervention |
|---|---|
| Mortality in First 7 Days of Life | 0 |
Collected over 24 hours following allocation to the DING intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DING Intervention | 0/20 (0%) | 3/20 (15%) | 0/20 (0%) |
| Event | DING Intervention |
|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 3/20 |
| Age, Customized(weeks) | DING Intervention |
|---|---|
| Gestational Age | 38.7 ± 0.5 |
| Sex: Female, Male(Participants) | DING Intervention |
|---|---|
| Female | 5 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | DING Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Oct 2018, 11 months.
Results were first posted in Dec 2019, 1 year 2 months after primary completion.
Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Hernias, Diaphragmatic, Congenital →
Children's Hospital of Philadelphia →