Umbilical Cord ClampingNCT06408376

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

A study testing Physiological cord clamping in people with Umbilical Cord Clamping and Congenital Diaphragmatic Hernia, run by Hospital JP Garrahan at 1 site in Argentina.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Umbilical Cord Clamping, Congenital Diaphragmatic Hernia, Delayed Umbilical Cord Separation
What is being tested?: Physiological cord clamping
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteArgentina
Study dates: 14 Jun 2022to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mariela Jozefkowicz contact

+5491164646270

mjozefkowicz@garrahan.gov.ar

Maria T Mazzucchelli contact

+5491149170437

mtmazzu@gmail.com

Argentina1 site, 1 recruiting

Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"
Buenos Aires, C1245AAM
Mariela Jozefkowicz, +5491164646270, mjozefkowicz@garrahan.gov.ar
Maria T Mazzucchelli, +5491149170437, mtmazzu@gmail.com
Recruiting

Other trials in Argentina

About this study

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.

Read the detailed description

Type of study: Randomized clinical trial
Primary objective: To establish the effectiveness of PFC in reducing hypoxia and improving cardiac output compared to immediate postintubation clamping in newborns with CDH. To establish the safety and feasibility of PFC after pulmonary recruitment achieved post intubation.
Secondary objectives: describe the evolution of patients with CDH 24 hours after birth under pre-established conditions. Relate prenatal indices to the subsequent evolution of these patients. Describe maternal evolution and postpartum complications.
Population: Patients who attend the Fetal Diagnosis and Treatment program of Garrahan Children's Hospital and undergo prenatal diagnosis of CDH are possible candidates. The study will be carried out in the Neonatal Intensive Care Unit of said hospital.
Scope of the study: Garrahan Children's Hospital is a level 3 B pediatric hospital and national referral center located in Autonomous City of Buenos Aires, Argentina. Center that receives neonates with CDH referred from all over the country as well as from other countries in the region and carries out the relevant training for equal reception.
Block randomization: will be carried out on the same day, 2 hours before entering the delivery room
Intervention: Immediately after birth, the newborn will be placed on a mobile table, made to received these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact, intubated and gently ventilated (positive inspiration pressure (PIM) 15/25 - positive end expiratory pressure (PEEP)4 - fraction of inspired oxygen inspired oxygen fraction (FiO2) 50%), until saturation >85% and heart rate (HR) >100 or 10 timed minutes pass, whichever occurs first, the umbilical cord will be clamped and continued with the usual reception steps in accordance with the unit´s CDH reception protocol.
Sample size: To calculate the sample size, a prevalence of hemodynamic alterations of 60% was considered in the first 24 hours of life of patients with CDH, following unit statistics and the aforementioned bibliography. The estimated sample size with a relative reduction of 50%: reduction from 60% to 30% of hemodynamic alterations - Power of 80% - Two-tailed test - alpha 5%. 40 patients required in each branch.

Conditions: Umbilical Cord Clamping, Congenital Diaphragmatic Hernia, Delayed Umbilical Cord Separation
Being tested: Physiological cord clamping
Medical subject headings: Hernias, Diaphragmatic, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physiological cord clampingProcedure or 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.

Study groups in NCT06408376
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 hours of life
complete delivery according group
Complete the protocol in the delivery room pre-established according to randomization (yes/no)
Measured: delivery

Secondary outcomes (31)

Gestational age at diagnosis
Gestational age at diagnosis of CDH in weeks
Measured: 1st day of life
Lung heart rate index observed/expected LHR O/E
lung heart rate index observed/expected (LHR O/E)
Measured: from 26 to 32 weeks of gestational age
liver in thorax
liver in thorax (yes/no) and %
Measured: from 26 to 32 weeks of gestational age
stomach herniation
stomach herniation (yes/no) and %
Measured: from 26 to 32 weeks of gestational age
lung volumen
lung volumen in RMI
Measured: from 26 to 32 weeks of gestational age
Mcgoon
Mcgoon Index in fetal echocardiogram
Measured: from 26 to 32 weeks of gestational age
maternal hematocrit
maternal hematocrit in gr/dl
Measured: 1 day before delivery
Intubation time
Time to intubation (minutes, seconds)
Measured: From delivery to intubation
Cord clamping time
Cord clamping time (minutes, seconds)
Measured: from delivery to cord clamping
Advance resuscitation need on delivery room
Requirement for advanced resuscitation (yes/no) (compressions, drugs, hypothermia)
Measured: from delivery to 30 minutes of life
Time to reach heart rate (HR) >100
Time to reach HR >100 (minutes, seconds)
Measured: from delivery to 30 minutes of life
Time to reach saturation (SAT) >85%
Time to reach SAT >85% (minutes, seconds)
Measured: from delivery to 30 minutes of life
Cord PH value
cord ph value
Measured: inmediatly after cord clampping
Cord lactic acid value
cord lactic acid value in mmol/l
Measured: inmediatly after cord clampping
saturation at 10 minutes
pre and post ductal saturation %
Measured: 10 minutes of life
Arterial pressure at 10 minutes
mean arterial tension in mmhg
Measured: 10 minutes of life
placenta abruption
Time for placental abruption (minutes, seconds)
Measured: 30 minutes of life
Mother arterial tension after delivery
mothers arterial mean tension after delivery in mmhg
Measured: 10 minutes after delivery
Uterotonic use
uterotonics use on mothers after delivery (yes/no)
Measured: 30 minutes after delivery
Evolution of patient Blood preassure (BP)
Blood pressure in mmhg
Measured: 2 - 4 hours and 24 hours of life
Evolution of patient inotropes required
Inotrope requirement (yes/no)
Measured: 2 - 4 hours and 24 hours of life
Inhaled nitric oxide (NOi) requirement
NOi requirement (yes/no)
Measured: 2 - 4 hours and 24 hours of life
ventilation requirements on the first day
Ventilatory mode / mean airway pressure (MAP)/ FIo2 %
Measured: 2 - 4 hours and 24 hours of life
Oxygenation on the first day
Partial arterial pressure of oxygen (PaO2) mmhg
Measured: 2 - 4 hours and 24 hours of life
Oxygenation index (OI) on the first day
OI
Measured: 2 - 4 hours and 24 hours of life
near-infrared spectroscopy (Nirs) on the first day
Cerebral and somatic NIRS
Measured: 2 - 4 hours and 24 hours of life
B natriuretic peptide (BNP) on the first day
B natriuretic peptide (BNP)
Measured: 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)
Measured: 6 and 24 hours of life
cardiac malformations
cardiac malformation (yes/no)
Measured: 6 hours of life
Mortality
Mortality (yes/no)
Measured: through study completion, an average of 1 year
Admission to ECMO
Admission to ECMO after the first 24 hours (yes/no)
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 202231 Dec 2026

First posted10 May 2024
Study start14 Jun 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Umbilical Cord ClampingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06408376
Sponsor's protocol ID: 1362
Other IDs: 6721
Status last verified: May 2024
First submitted: 22 Jan 2024
Last updated: 10 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Langham MR Jr, Kays DW, Ledbetter DJ, Frentzen B, Sanford LL, Richards DS. Congenital diaphragmatic hernia. Epidemiology and outcome. Clin Perinatol. 1996 Dec;23(4):671-88.
PubMed 8982563
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.
PubMed 17436304
Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.
PubMed 27077664
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.
PubMed 23401615
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.
PubMed 25689406
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.
PubMed 25671807
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.
PubMed 32170029
Hooper SB, Polglase GR, te Pas AB. A physiological approach to the timing of umbilical cord clamping at birth. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F355-60. doi: 10.1136/archdischild-2013-305703. Epub 2014 Dec 24.
PubMed 25540147
Lefebvre C, Rakza T, Weslinck N, Vaast P, Houfflin-Debarge V, Mur S, Storme L; French CDH Study Group. Feasibility and safety of intact cord resuscitation in newborn infants with congenital diaphragmatic hernia (CDH). Resuscitation. 2017 Nov;120:20-25. doi: 10.1016/j.resuscitation.2017.08.233. Epub 2017 Aug 30.
PubMed 28860014
Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA; Cord Pilot Trial Collaborative Group. Randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F6-F14. doi: 10.1136/archdischild-2016-312567. Epub 2017 Sep 18.
PubMed 28923985
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.
PubMed 26473001
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.
PubMed 31529790
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.
PubMed 28526223
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.
PubMed 31194603
Kashyap AJ, Hodges RJ, Thio M, Rodgers KA, Amberg BJ, McGillick EV, Hooper SB, Crossley KJ, DeKoninck PLJ. Physiologically based cord clamping improves cardiopulmonary haemodynamics in lambs with a diaphragmatic hernia. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):18-25. doi: 10.1136/archdischild-2019-316906. Epub 2019 May 23.
PubMed 31123056

Interested in taking part?

Mariela Jozefkowicz

+5491164646270

mjozefkowicz@garrahan.gov.ar

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
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30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Not yet recruiting
"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"
Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes
Recruiting
Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality

All Umbilical Cord Clamping trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial
ClinicalTrials.gov ID: NCT06408376
Acronym / sponsor ID: 1362
Conditions: Umbilical Cord Clamping, Congenital Diaphragmatic Hernia, Delayed Umbilical Cord Separation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Hospital JP GarrahanOther government
Study start: 14 Jun 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 10 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Type of study: Randomized clinical trial
Primary objective: To establish the effectiveness of PFC in reducing hypoxia and improving cardiac output compared to immediate postintubation clamping in newborns with CDH. To establish the safety and feasibility of PFC after pulmonary recruitment achieved post intubation.
Secondary objectives: describe the evolution of patients with CDH 24 hours after birth under pre-established conditions. Relate prenatal indices to the subsequent evolution of these patients. Describe maternal evolution and postpartum complications.
Population: Patients who attend the Fetal Diagnosis and Treatment program of Garrahan Children's Hospital and undergo prenatal diagnosis of CDH are possible candidates. The study will be carried out in the Neonatal Intensive Care Unit of said hospital.
Scope of the study: Garrahan Children's Hospital is a level 3 B pediatric hospital and national referral center located in Autonomous City of Buenos Aires, Argentina. Center that receives neonates with CDH referred from all over the country as well as from other countries in the region and carries out the relevant training for equal reception.
Block randomization: will be carried out on the same day, 2 hours before entering the delivery room
Intervention: Immediately after birth, the newborn will be placed on a mobile table, made to received these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact, intubated and gently ventilated (positive inspiration pressure (PIM) 15/25 - positive end expiratory pressure (PEEP)4 - fraction of inspired oxygen inspired oxygen fraction (FiO2) 50%), until saturation >85% and heart rate (HR) >100 or 10 timed minutes pass, whichever occurs first, the umbilical cord will be clamped and continued with the usual reception steps in accordance with the unit´s CDH reception protocol.
Sample size: To calculate the sample size, a prevalence of hemodynamic alterations of 60% was considered in the first 24 hours of life of patients with CDH, following unit statistics and the aforementioned bibliography. The estimated sample size with a relative reduction of 50%: reduction from 60% to 30% of hemodynamic alterations - Power of 80% - Two-tailed test - alpha 5%. 40 patients required in each branch.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
physiological umbilical cord clamping	Experimental	Procedure: Physiological cord clampingImmediately 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.
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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physiological cord clampingImmediately 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.	Procedure or surgery	physiological umbilical cord clamping

Primary outcome

Hemodynamic deterioration in the first 24 hours of life
Time frame: 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
complete delivery according group
Time frame: delivery
Complete the protocol in the delivery room pre-established according to randomization (yes/no)

31 secondary outcomes

Gestational age at diagnosis
Time frame: 1st day of life
Lung heart rate index observed/expected LHR O/E
Time frame: from 26 to 32 weeks of gestational age
liver in thorax
Time frame: from 26 to 32 weeks of gestational age
stomach herniation
Time frame: from 26 to 32 weeks of gestational age
lung volumen
Time frame: from 26 to 32 weeks of gestational age
Mcgoon
Time frame: from 26 to 32 weeks of gestational age
maternal hematocrit
Time frame: 1 day before delivery
Intubation time
Time frame: From delivery to intubation
Cord clamping time
Time frame: from delivery to cord clamping
Advance resuscitation need on delivery room
Time frame: from delivery to 30 minutes of life
Time to reach heart rate (HR) >100
Time frame: from delivery to 30 minutes of life
Time to reach saturation (SAT) >85%
Time frame: from delivery to 30 minutes of life
Cord PH value
Time frame: inmediatly after cord clampping
Cord lactic acid value
Time frame: inmediatly after cord clampping
saturation at 10 minutes
Time frame: 10 minutes of life
Arterial pressure at 10 minutes
Time frame: 10 minutes of life
placenta abruption
Time frame: 30 minutes of life
Mother arterial tension after delivery
Time frame: 10 minutes after delivery
Uterotonic use
Time frame: 30 minutes after delivery
Evolution of patient Blood preassure (BP)
Time frame: 2 - 4 hours and 24 hours of life
Evolution of patient inotropes required
Time frame: 2 - 4 hours and 24 hours of life
Inhaled nitric oxide (NOi) requirement
Time frame: 2 - 4 hours and 24 hours of life
ventilation requirements on the first day
Time frame: 2 - 4 hours and 24 hours of life
Oxygenation on the first day
Time frame: 2 - 4 hours and 24 hours of life
Oxygenation index (OI) on the first day
Time frame: 2 - 4 hours and 24 hours of life
near-infrared spectroscopy (Nirs) on the first day
Time frame: 2 - 4 hours and 24 hours of life
B natriuretic peptide (BNP) on the first day
Time frame: 24 hours of life
PH value on the first day
Time frame: 6 and 24 hours of life
cardiac malformations
Time frame: 6 hours of life
Mortality
Time frame: through study completion, an average of 1 year
Admission to ECMO
Time frame: through study completion, an average of 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Background: PubMed 8982563Langham MR Jr, Kays DW, Ledbetter DJ, Frentzen B, Sanford LL, Richards DS. Congenital diaphragmatic hernia. Epidemiology and outcome. Clin Perinatol. 1996 Dec;23(4):671-88.
Background: PubMed 17436304Keller 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.
Background: PubMed 27077664Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.
Background: PubMed 23401615Bhatt 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.
Background: PubMed 25689406Polglase 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.
Background: PubMed 25671807Hooper 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.
Background: PubMed 32170029Horn-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.
Background: PubMed 25540147Hooper SB, Polglase GR, te Pas AB. A physiological approach to the timing of umbilical cord clamping at birth. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F355-60. doi: 10.1136/archdischild-2013-305703. Epub 2014 Dec 24.
Background: PubMed 28860014Lefebvre C, Rakza T, Weslinck N, Vaast P, Houfflin-Debarge V, Mur S, Storme L; French CDH Study Group. Feasibility and safety of intact cord resuscitation in newborn infants with congenital diaphragmatic hernia (CDH). Resuscitation. 2017 Nov;120:20-25. doi: 10.1016/j.resuscitation.2017.08.233. Epub 2017 Aug 30.
Background: PubMed 28923985Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA; Cord Pilot Trial Collaborative Group. Randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F6-F14. doi: 10.1136/archdischild-2016-312567. Epub 2017 Sep 18.
Background: PubMed 26473001Wyckoff 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.
Background: PubMed 31529790Rabe 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Mariela Jozefkowicz contact

+5491164646270

mjozefkowicz@garrahan.gov.ar

Maria T Mazzucchelli contact

+5491149170437

mtmazzu@gmail.com

Mariela Jozefkowicz principal investigator

Hospital JP Garrahan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physiological cord clamping in people with Umbilical Cord Clamping and Congenital Diaphragmatic Hernia, run by Hospital JP Garrahan at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariela Jozefkowicz (+5491164646270, mjozefkowicz@garrahan.gov.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodynamic deterioration in the first 24 hours of life (time frame: 24 hours of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06408376, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.