Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial

NCT06408376 | Recruiting DMC

• 2 other identifiers: 13626721
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital diaphragmatic hernia (CDH) is a malformation that affects 1 in every 3000 newborns. The diaphragm does not complete its closure during embryogenesis, which allows the abdominal organs to herniate into the thoracic cavity altering lung development. The lungs of patients with CDH are small, with a decreased surface area for gas exchange and developmental impair of the pulmonary vasculature, resulting in respiratory failure and pulmonary hypertension shortly after birth. When clamping the umbilical cord, a large part of the preload is abruptly excluded, generating an increase in vascular resistance, which in turn increase the afterload, resulting in a decrease in cardiac output. The output is restored by decreasing vascular resistance in pulmonary circuit after lung aeration upon receiving the preload of the right atrium, increasing pulmonary flow and thus sustaining the preload of the left ventricle. If pulmonary aeration occurs before clamping the umbilical cord, the pulmonary blood flow increases before placenta flow is lost, thus avoiding a decrease in cardiac output. This modality has been called physiological base cord clamping (PFC). The hypothesis is that PFC once ventilation has been established could prevent hypoxia and improve cardiac output in newborns with CDH and secondarily improve their hemodynamic parameters, stabilizing gas exchange and pulmonary hypertension during the first 24 hours of birth.

Conditions

Umbilical Cord Clamping; Congenital Diaphragmatic Hernia; Delayed Umbilical Cord Separation

Outcome Measures

Primary Outcomes (2)

• Hemodynamic deterioration in the first 24 hours of life

  Hemodynamic deterioration in the first 24 hours of life (meeting 3 of 4 of the following criteria or entry to extracorporeal membrane oxygenation (ECMO) or Death). 1. Pre/post ductal saturation difference \>10% 2. Oxygenation index (IO) \>20 3. mean arterial pressure \< Percentile 50 or inotrope requirement 4. Lactic acid \>3 mmol/l

  24 hours of life

• complete delivery according group

  Complete the protocol in the delivery room pre-established according to randomization (yes/no)

  delivery

Secondary Outcomes (31)

• Gestational age at diagnosis

  1st day of life

• Lung heart rate index observed/expected LHR O/E

  from 26 to 32 weeks of gestational age

• liver in thorax

  from 26 to 32 weeks of gestational age

• stomach herniation

  from 26 to 32 weeks of gestational age

• lung volumen

  from 26 to 32 weeks of gestational age

Other Outcomes (24)

• maternal age

  through study completion, an average of 1 year

• maternal history

  through study completion, an average of 1 year

• baby weight

  30 minutes of life

Study Arms (2)

physiological umbilical cord clamping

EXPERIMENTAL

Immediately after birth, the newborn will be placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact and will be intubated. The patient will be gently ventilated (PIM 15/25 - PEEP 4 - Fio2 50%), until saturation \>85% and HR\>100 or 10 timed minutes have elapsed, whichever occurs first, the umbilical cord will be clamped and the procedures continued usual reception steps according to the unit´s CDH reception protocol.

Procedure: Physiological cord clamping

usual reception

NO INTERVENTION

Immediately after birth, the newborn is placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact will be intubated. According to the unit´s CDH reception protocol, patients with CDH cord clamping is done post intubation

Interventions

Physiological cord clamping PROCEDURE

Immediately after birth, the newborn with prenatal diagnosis of CDH will be placed on a mobile table, made to receive these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact and intubated. The patient will be gently ventilated (PIM 15/25 - PEEP 4 - Fio2 50%), until saturation \>85% and HR\>100 or 10 timed minutes have elapsed, whichever occurs first, the umbilical cord will be clamped.

physiological umbilical cord clamping

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prenatal diagnosis of congenital diaphragmatic hernia
• gestational age \>34 weeks
• Informed consent signed by the patient's parents

You may not qualify if:

• Multiple gestation
• Major malformation or fetal genetic anomaly diagnosed in the prenatal stage
• Emergency cesarean section or maternal condition that prevents the approach
• Lack of informed consent

Sponsors & Collaborators

• Hospital JP Garrahan: lead

Study Sites (1)

Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"

Buenos Aires, C1245AAM, Argentina

RECRUITING

Related Publications (20)

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  PMID: 8982563 BACKGROUND

• Keller RL. Antenatal and postnatal lung and vascular anatomic and functional studies in congenital diaphragmatic hernia: implications for clinical management. Am J Med Genet C Semin Med Genet. 2007 May 15;145C(2):184-200. doi: 10.1002/ajmg.c.30130.

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• 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 BACKGROUND

• Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015.

  PMID: 25689406 BACKGROUND

• Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4.

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• Horn-Oudshoorn EJJ, Knol R, Te Pas AB, Hooper SB, Cochius-den Otter SCM, Wijnen RMH, Schaible T, Reiss IKM, DeKoninck PLJ. Perinatal stabilisation of infants born with congenital diaphragmatic hernia: a review of current concepts. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):449-454. doi: 10.1136/archdischild-2019-318606. Epub 2020 Mar 13.

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  PMID: 28860014 BACKGROUND

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  PMID: 28923985 BACKGROUND

• Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.

  PMID: 26473001 BACKGROUND

• Rabe H, Gyte GM, Diaz-Rossello JL, Duley L. 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. 2019 Sep 17;9(9):CD003248. doi: 10.1002/14651858.CD003248.pub4.

  PMID: 31529790 BACKGROUND

• Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.

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• McGillick EV, Davies IM, Hooper SB, Kerr LT, Thio M, DeKoninck P, Yamaoka S, Hodges R, Rodgers KA, Zahra VA, Moxham AM, Kashyap AJ, Crossley KJ. Effect of lung hypoplasia on the cardiorespiratory transition in newborn lambs. J Appl Physiol (1985). 2019 Aug 1;127(2):568-578. doi: 10.1152/japplphysiol.00760.2018. Epub 2019 Jun 13.

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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

• Mariela Jozefkowicz

  Hospital JP Garrahan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariela Jozefkowicz

CONTACT

+5491164646270; mjozefkowicz@garrahan.gov.ar

Maria T Mazzucchelli

CONTACT

+5491149170437; mtmazzu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: May 10, 2024
• Study Start: June 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)