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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital JP Garrahan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prenatal diagnosis of congenital diaphragmatic hernia

gestational age >34 weeks

Informed consent signed by the patient's parents

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Physiological cord clamping

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: physiological umbilical cord clampingExperimental treatment 1 intervention
Group B: usual receptionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours of life
2

complete delivery according group

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

Time frame
delivery

Secondary outcomes

1

Gestational age at diagnosis

Gestational age at diagnosis of CDH in weeks

Time frame
1st day of life
2

Lung heart rate index observed/expected LHR O/E

lung heart rate index observed/expected (LHR O/E)

Time frame
from 26 to 32 weeks of gestational age
3

liver in thorax

liver in thorax (yes/no) and %

Time frame
from 26 to 32 weeks of gestational age
4

stomach herniation

stomach herniation (yes/no) and %

Time frame
from 26 to 32 weeks of gestational age

Other outcomes

1

maternal age

maternal age during pregnancy

Time frame
through study completion, an average of 1 year
2

maternal history

maternal pathological history during pregnancy (yes/no)

Time frame
through study completion, an average of 1 year
3

baby weight

Weight in grams

Time frame
30 minutes of life
4

Patent ductus arteriosus (PAD) on the first day (size)

Patent ductus arteriosus (PAD): size in milimeters

Time frame
6 and 24 hours of life

Sponsors and contacts

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