NCT03314233: DING

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

Completed NA Results posted Last updated 21 January 2020

What this trial tests

NA trial testing DING in Congenital Diaphragmatic Hernia in 21 participants. Completed in 9 October 2018.

Timeline

12 October 2017

Primary endpoint
1 October 2018

9 October 2018

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	21
Start date	12 October 2017
Primary completion	1 October 2018
Estimated completion	9 October 2018
Sites	1 location across United States

Drugs / interventions tested

• DING

Conditions studied

• Congenital Diaphragmatic Hernia — all drugs for Congenital Diaphragmatic Hernia →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 1 Day to 1 Day, any sex, with Congenital Diaphragmatic Hernia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping Primary · 3 minutes of life

Infants who are intubated and have ventilation initiated prior to umbilical cord clamping

Group	Value	95% CI
DING Intervention	17

Mean Arterial Potential of Hydrogen (pH) in Arterial Blood Secondary · Approximately 1 hour of life

Arterial pH on first blood gas

Group	Value	95% CI
DING Intervention	7.02	± 0.15

Mean Partial Pressure of O2 in Arterial Blood (PaO2) Secondary · Approximately 1 hour of life

Arterial PaO2 on first blood gas

Group	Value	95% CI
DING Intervention	47	39 – 52

Oxygenation Index (OI) Secondary · First obtained blood gas

Oxygenation index \[OI\] with first obtained blood gas

Group	Value	95% CI
DING Intervention	17.5	12.8 – 25.5

Proportion of Infants Who Require Vasopressors Secondary · First 48 hours of life

Proportion of infants who require vasopressors in first 48 hours of life

Group	Value	95% CI
DING Intervention	13

Presence of Severe Pulmonary Hypertension Secondary · Approximately 24 hours of life

Presence of severe pulmonary hypertension on first echocardiogram

Group	Value	95% CI
DING Intervention	12

Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment Secondary · 7 days of life

Proportion of infants who require ECMO treatment in first 7 days of life

Group	Value	95% CI
DING Intervention	7

Mortality in First 7 Days of Life Secondary · First 7 days of life

Proportion of infants with mortality in the first 7 days of life

Group	Value	95% CI
DING Intervention	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours following allocation to the DING intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DING Intervention

Serious: 3/20 (15%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	DING Intervention
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pneumothorax.

Data from ClinicalTrials.gov NCT03314233 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Initiating resuscitation before umbilical cord clamping in infants with congenital diaphragmatic hernia: a pilot feasibility trial.
   Foglia EE, Ades A, Hedrick HL, Rintoul N, et al · · 2020 · cited 29× · PMID 31462406 · DOI 10.1136/archdischild-2019-317477
2. Placental Transfusion for Asphyxiated Infants.
   Katheria AC, Rich WD, Bava S, Lakshminrusimha S. · · 2019 · cited 11× · PMID 31824895 · DOI 10.3389/fped.2019.00473
3. Congenital diaphragmatic hernia: 25 years of shared knowledge; what about survival?
   Lakshminrusimha S, Vali P. · · 2020 · cited 4× · PMID 31629706 · DOI 10.1016/j.jped.2019.10.002