Delayed Cord Clamping for Congenital Diaphragmatic Hernia

NCT03314233 | Completed Results DMC

• 2 other identifiers: 17-014125K23HD084727
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

• Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping

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

  3 minutes of life

Secondary Outcomes (7)

• Mean Arterial Potential of Hydrogen (pH) in Arterial Blood

  Approximately 1 hour of life

• Mean Partial Pressure of O2 in Arterial Blood (PaO2)

  Approximately 1 hour of life

• Oxygenation Index (OI)

  First obtained blood gas

• Proportion of Infants Who Require Vasopressors

  First 48 hours of life

• Presence of Severe Pulmonary Hypertension

  Approximately 24 hours of life

Study Arms (1)

DING intervention

EXPERIMENTAL

Delayed Cord Clamping

Procedure: DING

Interventions

DING PROCEDURE

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.

DING intervention

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment
• Gestational age ≥ 36 weeks at birth

You may not qualify if:

• Multiple gestation
• Major anomalies or aneuploidy
• Enrolled in fetal endoluminal tracheal occlusion (FETO) trial
• Palliative care planned or considered
• Maternal diagnosis placenta previa, accreta, or abruption
• Maternal diagnosis pre-eclampsia requiring Magnesium sulfate therapy at time of delivery
• Obstetrics (OB) or Neonatal provider concerns for the clinical care of the mother or infant, or study team not available

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Grover TR, Murthy K, Brozanski B, Gien J, Rintoul N, Keene S, Najaf T, Chicoine L, Porta N, Zaniletti I, Pallotto EK; Children's Hospitals Neonatal Consortium. Short-term outcomes and medical and surgical interventions in infants with congenital diaphragmatic hernia. Am J Perinatol. 2015 Sep;32(11):1038-44. doi: 10.1055/s-0035-1548729. Epub 2015 Mar 31.

  PMID: 25825963 BACKGROUND

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elizabeth Foglia
• Organization: Childrens Hospital of Philadelphia

foglia@email.chop.edu

215-590-1653

Study Officials

• Elizabeth Foglia, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded single-arm pilot interventional trial. All enrolled infants will receive the DING intervention (Delayed cord clamping for INtubation and Gentle ventilation)

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 19, 2017
• Study Start: October 12, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 9, 2018
• Last Updated: January 21, 2020
• Results First Posted: December 10, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)