An interventional study of Physiological cord clamping in Umbilical Cord Clamping, Congenital Diaphragmatic Hernia and Delayed Umbilical Cord Separation, sponsored by Hospital JP Garrahan. Recruiting at 1 site in Argentina. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Hospital JP Garrahan · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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
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
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.
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
complete delivery according group
Complete the protocol in the delivery room pre-established according to randomization (yes/no)
Time frame: delivery
Gestational age at diagnosis
Gestational age at diagnosis of CDH in weeks
Time frame: 1st day of life
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
liver in thorax
liver in thorax (yes/no) and %
Time frame: from 26 to 32 weeks of gestational age
stomach herniation
stomach herniation (yes/no) and %
Time frame: from 26 to 32 weeks of gestational age
lung volumen
lung volumen in RMI
Time frame: from 26 to 32 weeks of gestational age
Mcgoon
Mcgoon Index in fetal echocardiogram
Time frame: from 26 to 32 weeks of gestational age
maternal hematocrit
maternal hematocrit in gr/dl
Time frame: 1 day before delivery
Intubation time
Time to intubation (minutes, seconds)
Time frame: From delivery to intubation
Cord clamping time
Cord clamping time (minutes, seconds)
Time frame: from delivery to cord clamping
Advance resuscitation need on delivery room
Requirement for advanced resuscitation (yes/no) (compressions, drugs, hypothermia)
Time frame: from delivery to 30 minutes of life
Time to reach heart rate (HR) >100
Time to reach HR \>100 (minutes, seconds)
Time frame: from delivery to 30 minutes of life
Time to reach saturation (SAT) >85%
Time to reach SAT \>85% (minutes, seconds)
Time frame: from delivery to 30 minutes of life
Cord PH value
cord ph value
Time frame: inmediatly after cord clampping
Cord lactic acid value
cord lactic acid value in mmol/l
Time frame: inmediatly after cord clampping
saturation at 10 minutes
pre and post ductal saturation %
Time frame: 10 minutes of life
Arterial pressure at 10 minutes
mean arterial tension in mmhg
Time frame: 10 minutes of life
placenta abruption
Time for placental abruption (minutes, seconds)
Time frame: 30 minutes of life
Mother arterial tension after delivery
mothers arterial mean tension after delivery in mmhg
Time frame: 10 minutes after delivery
Uterotonic use
uterotonics use on mothers after delivery (yes/no)
Time frame: 30 minutes after delivery
Evolution of patient Blood preassure (BP)
Blood pressure in mmhg
Time frame: 2 - 4 hours and 24 hours of life
Evolution of patient inotropes required
Inotrope requirement (yes/no)
Time frame: 2 - 4 hours and 24 hours of life
Inhaled nitric oxide (NOi) requirement
NOi requirement (yes/no)
Time frame: 2 - 4 hours and 24 hours of life
ventilation requirements on the first day
Ventilatory mode / mean airway pressure (MAP)/ FIo2 %
Time frame: 2 - 4 hours and 24 hours of life
Oxygenation on the first day
Partial arterial pressure of oxygen (PaO2) mmhg
Time frame: 2 - 4 hours and 24 hours of life
Oxygenation index (OI) on the first day
OI
Time frame: 2 - 4 hours and 24 hours of life
near-infrared spectroscopy (Nirs) on the first day
Cerebral and somatic NIRS
Time frame: 2 - 4 hours and 24 hours of life
B natriuretic peptide (BNP) on the first day
B natriuretic peptide (BNP)
Time frame: 24 hours of life
PH value on the first day
echocardiographic pulmonary hypertension PH (\<50% of systemic pressure, between 50-80% of systemic pressure, between 80 and 100% of systemic pressure, systemic, suprasystemic)
Time frame: 6 and 24 hours of life
cardiac malformations
cardiac malformation (yes/no)
Time frame: 6 hours of life
Mortality
Mortality (yes/no)
Time frame: through study completion, an average of 1 year
Admission to ECMO
Admission to ECMO after the first 24 hours (yes/no)
Time frame: through study completion, an average of 1 year
maternal age
maternal age during pregnancy
Time frame: through study completion, an average of 1 year
maternal history
maternal pathological history during pregnancy (yes/no)
Time frame: through study completion, an average of 1 year
baby weight
Weight in grams
Time frame: 30 minutes of life
Patent ductus arteriosus (PAD) on the first day (size)
Patent ductus arteriosus (PAD): size in milimeters
Time frame: 6 and 24 hours of life
Patent ductus arteriosus (PAD) on the first day (gradient)
Patent ductus arteriosus (PAD): gradient
Time frame: 6 and 24 hours of life
Patent ductus arteriosus (PAD) on the first day (shunt direction)
Patent ductus arteriosus (PAD): shunt direction
Time frame: 6 and 24 hours of life
Patent foramen ovale (PFO) on the first day (shunt direction)
Patent foramen ovale (PFO): shunt direction.
Time frame: 6 and 24 hours of life
Right ventricle (RV) on the first day diameter
Right ventricle (RV): RV diameter in milimeters
Time frame: 6 and 24 hours of life
Right ventricle (RV) on the first day TAPSE
Right ventricle (RV): TAPSE
Time frame: 6 and 24 hours of life
Tricuspide Insufitienty
tricuspide insufitienty
Time frame: 6 and 24 hours of life
Right ventricle funtion
Right ventricle global disfuntion : no, mild, moderate or severe
Time frame: 6 and 24 hours of life
Left ventricle (LV) on the first day (eccentricity index)
Left ventricle (LV): eccentricity index
Time frame: 6 and 24 hours of life
Left ventricle (LV) on the first day (ejection fraction)
Left ventricle (LV): ejection fraction (EF)
Time frame: 6 and 24 hours of life
Left ventricle (LV) on the first day global funtion
Left ventricle (LV) global disfuntion : no, global disfuntion : no, mild, moderate or severe
Time frame: 6 and 24 hours of life
Interventricular septum (IS) on the first day
Interventricular septum: configuration
Time frame: 6 and 24 hours of life
Pulmonary hypertation grade on the first day
Pulmonary hypertation: no, mild, moderate or severe
Time frame: 6 and 24 hours of life
Associated malformations
Associated malformations (yes/no), which
Time frame: 24 hours of life
Chromosomopathy or genetic alteration
Chromosomopathy or genetic alteration (yes/no), which
Time frame: through study completion, an average of 1 year
Hyperbilirubinemia
Hyperbilirubinemia requiring phototherapy or exchange transfusion (yes/no)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Early sepsis
Early sepsis (yes/no)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Omphalitis
Omphalitis (yes/no)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
CDH surgery
CDH surgery (yes/no), days of life
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Surgical classification
Surgical classification of CDH (a-b-c-d)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Days in neonatal intensive care unit (NICU)
Days in NICU
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Plan to share: No
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Hernias, Diaphragmatic, Congenital→
Hospital JP Garrahan