Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord

NCT03242044 | Completed

• 1 other identifier: 17-0788
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital diaphragmatic hernia (CDH) is a severe birth defect, with a prevalence of 1:2000 to 1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal contents into the chest with subsequent compression of the intrathoracic structures and respiratory insufficiency after birth. Respiratory insufficiency is managed with intubation and mechanical ventilation. In addition to managing respiratory insufficiency, intubation prevents entrainment of air into the intestines and further compression of the lungs and heart. Resuscitation of infants with CDH also involves placement of a nasogastric tube (NG) into the stomach for removal of entrained air and secretions. As part of routine resuscitation in infants with CDH intubation and NG tube placement are performed after the delivery personnel separates the baby from the placenta by cutting the umbilical cord. This study will assess the feasibility, maternal and fetal tolerance and the optimal approach to performing these initial steps of resuscitation with an intact umbilical cord. The investigators have randomly chosen 10 maternal and infant with congenital diaphragmatic hernia dyads to demonstrate feasibility as well as determine pitfalls and difficulties and the optimal approach to a complex resuscitation with an intact umbilical cord.

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

• Tolerance of resuscitation on infants with congenital diaphragmatic hernia with an intact umbilical cord.

  10 maternal and infant with left or right sided congenital diaphragmatic hernia dyads will be enrolled in the study and maternal and infant tolerance to resuscitation with an intact umbilical cord determined. Maternal tolerance will be assessed by the incidence of post-partum hemorrhage and uterine atony, infant tolerance determined by capillary blood gas assessments of pH, pCO2 and base deficit and the incidence of bradycardia lasting greater than 1 minute.

  5 minutes

Secondary Outcomes (3)

• Feasibility of resuscitation on infants with congenital diaphragmatic hernia with an intact umbilical cord.

  5 minutes

• Evaluation of Infant gas exchange after clamping the umbilical cord

  10 minutes

• Left ventricular function after resuscitation with an intact umbilical cord

  20 minutes

Study Arms (1)

Resuscitation with intact umbilical cord

EXPERIMENTAL

This is a one arm study. Pregnant women greater than 18 years of age with a fetus with left or right sided congenital diaphragmatic hernia of age that consent to the protocol will be enrolled in the study. This is a pilot feasibility study that will assess maternal and infant tolerance to resuscitation with an intact umbilical cord as well as the optimal method for performing an advanced resuscitation with the umbilical cord intact. For this reason patients will not be randomized.

Procedure: Congenital diaphragmatic hernia resuscitation with an intact umbilical cord

Interventions

Congenital diaphragmatic hernia resuscitation with an intact umbilical cord PROCEDURE

10 infants with left or right sided congenital diaphragmatic hernia will be intubated and ventilation initiated while still attached to the placental circulation through the umbilical cord. In addition, at the same time, a nasogastric tube will be placed in the stomach to drain entrained air and secretions. After 5 minutes of resuscitation with the umbilical cord intact, the umbilical cord will be cut, infants separated from the placenta and resuscitation performed per routine neonatal resuscitation protocols. Feasibility, the optimal approach and maternal and infant tolerance to the procedure will be assessed as part of the study.

Resuscitation with intact umbilical cord

Eligibility Criteria

• Age: Up to 5 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pregnant women 18 years of age and older with a fetus with the diagnosis of left and right sided congenital diaphragmatic hernia who consent to the protocol.

You may not qualify if:

• Patients with Morgagni type defects.
• Infants that have undergone fetal endoscopic tracheal occlusion (FETO)
• Infants with CDH with chromosomal anomalies trisomy 18 and 13
• Infants with bilateral congenital diaphragmatic hernia

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (21)

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  PMID: 1290156 RESULT

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  PMID: 8071756 RESULT

• Vogel M, McElhinney DB, Marcus E, Morash D, Jennings RW, Tworetzky W. Significance and outcome of left heart hypoplasia in fetal congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2010 Mar;35(3):310-7. doi: 10.1002/uog.7497.

  PMID: 20143332 RESULT

• Taira Y, Yamataka T, Miyazaki E, Puri P. Comparison of the pulmonary vasculature in newborns and stillborns with congenital diaphragmatic hernia. Pediatr Surg Int. 1998 Nov;14(1-2):30-5. doi: 10.1007/s003830050429.

  PMID: 9880691 RESULT

• Van Loenhout RB, De Krijger RR, Van de Ven CP, Van der Horst IW, Beurskens LW, Tibboel D, Keijzer R. Postmortem biopsy to obtain lung tissue in congenital diaphragmatic hernia. Neonatology. 2013;103(3):213-7. doi: 10.1159/000345921. Epub 2013 Jan 12.

  PMID: 23328121 RESULT

• Reiss I, Schaible T, van den Hout L, Capolupo I, Allegaert K, van Heijst A, Gorett Silva M, Greenough A, Tibboel D; CDH EURO Consortium. Standardized postnatal management of infants with congenital diaphragmatic hernia in Europe: the CDH EURO Consortium consensus. Neonatology. 2010;98(4):354-64. doi: 10.1159/000320622. Epub 2010 Oct 27.

  PMID: 20980772 RESULT

• Biban P, Filipovic-Grcic B, Biarent D, Manzoni P; International Liaison Committee on Resuscitation (ILCOR); European Resuscitation Council (ERC); American Heart Association (AHA); American Academy of Pediatrics (AAP). New cardiopulmonary resuscitation guidelines 2010: managing the newly born in delivery room. Early Hum Dev. 2011 Mar;87 Suppl 1:S9-11. doi: 10.1016/j.earlhumdev.2011.01.002. Epub 2011 Jan 19.

  PMID: 21251771 RESULT

• Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.

  PMID: 24055300 RESULT

• Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003248. doi: 10.1002/14651858.CD003248.pub3.

  PMID: 22895933 RESULT

• Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.

  PMID: 28002310 RESULT

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  PMID: 17332197 RESULT

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  PMID: 28372510 RESULT

• Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.

  PMID: 17890882 RESULT

• Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.

  PMID: 16585320 RESULT

• Backes CH, Huang H, Cua CL, Garg V, Smith CV, Yin H, Galantowicz M, Bauer JA, Hoffman TM. Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial. J Perinatol. 2015 Oct;35(10):826-31. doi: 10.1038/jp.2015.89. Epub 2015 Jul 30.

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• Boere I, Roest AA, Wallace E, Ten Harkel AD, Haak MC, Morley CJ, Hooper SB, te Pas AB. Umbilical blood flow patterns directly after birth before delayed cord clamping. Arch Dis Child Fetal Neonatal Ed. 2015 Mar;100(2):F121-5. doi: 10.1136/archdischild-2014-307144. Epub 2014 Nov 11.

  PMID: 25389141 RESULT

• Hutchon DJ. Ventilation before Umbilical Cord Clamping Improves Physiological Transition at Birth or "Umbilical Cord Clamping before Ventilation is Established Destabilizes Physiological Transition at Birth". Front Pediatr. 2015 Apr 20;3:29. doi: 10.3389/fped.2015.00029. eCollection 2015. No abstract available.

  PMID: 25941666 RESULT

• Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11.

  PMID: 23401615 RESULT

• Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26.

  PMID: 27574999 RESULT

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

Study Officials

• Jason Gien, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a pilot feasibility study that will assess maternal and infant tolerance to the protocols as well as the optimal method for performing an advanced resuscitation with an intact umbilical cord. The investigators have randomly chosen 10 study participant to make this assessment and determine methodologies. For this reason study participants will not be randomized. Pregnant women greater than 18 years of age that consent to the protocol will be enrolled in the study arm.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 8, 2017
• Study Start: January 12, 2018
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)