ACTIVE_NOT_RECRUITING

Prone Positioning During Delayed Cord Clamping

Conditions

Delayed Cord Clamping Umbilical Cord Clamping Preterm Birth Delayed Cord Clamping (DCC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Delayed cord clamping is a routine technique used in the delivery room. The baby remains attached to the umbilical cord and placenta for 30-60 seconds after birth to allow for maximal transfer of oxygen and blood to the newborn. This study seeks to determine the best position (on the back versus on the belly) for the newborn during the 30-60 seconds of delayed cord clamping.

Official Title

Prone Positioning During Delayed Cord Clamping: A Randomized Control Pilot Study to Identify Optimal Neonatal Positioning During Delayed Cord Clamping

Quick Facts

Study Start:2022-08-09

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05507424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Pregnant patient admitted for diagnosis that could result in a preterm delivery * Anticipated gestational age of delivery could be between 25w+0d - 29w+6d * Fetus without major anomalies or known genetic condition that could impact respiratory status or need for intubation at birth * Singleton or twin gestation * Neonate eligible for delayed cord clamping based on institutional protocol * Patient is able to understand study procedures and is willing and able to consent	* Triplet or higher order gestation * Maternal or fetal/neonatal contraindication to delayed cord clamping * Major fetal anomaly that would be expected to impact delivery room intubation rates such as: * Major congenital cardiac defect (not isolated atrial septal defect/ventricular septal defect) * Significant fetal arrhythmia at the time of delivery * Fetal tumor * Renal anhydramnios (not isolated urinary tract dilation with normal fluid) * Congenital Diaphragmatic Hernia * Heterotaxy * Moderate to severe ventriculomegaly or other major brain malformation (not mild isolated ventriculomegaly) * Airway obstruction * Underlying genetic disease that could impact respiratory function at delivery * Arthrogryposis (not apparently isolated clubbed foot) * Skeletal dysplasia * Pregnant patient is unable to understand study materials or is unwilling or unable to consent * Acute maternal obstetric emergency that precludes time or maternal focus for the consent process to take place

Inclusion Criteria

Exclusion Criteria

* Pregnant patient admitted for diagnosis that could result in a preterm delivery
* Anticipated gestational age of delivery could be between 25w+0d - 29w+6d
* Fetus without major anomalies or known genetic condition that could impact respiratory status or need for intubation at birth
* Singleton or twin gestation
* Neonate eligible for delayed cord clamping based on institutional protocol
* Patient is able to understand study procedures and is willing and able to consent

* Triplet or higher order gestation
* Maternal or fetal/neonatal contraindication to delayed cord clamping
* Major fetal anomaly that would be expected to impact delivery room intubation rates such as:
* Major congenital cardiac defect (not isolated atrial septal defect/ventricular septal defect)
* Significant fetal arrhythmia at the time of delivery
* Fetal tumor
* Renal anhydramnios (not isolated urinary tract dilation with normal fluid)
* Congenital Diaphragmatic Hernia
* Heterotaxy
* Moderate to severe ventriculomegaly or other major brain malformation (not mild isolated ventriculomegaly)
* Airway obstruction
* Underlying genetic disease that could impact respiratory function at delivery
* Arthrogryposis (not apparently isolated clubbed foot)
* Skeletal dysplasia
* Pregnant patient is unable to understand study materials or is unwilling or unable to consent
* Acute maternal obstetric emergency that precludes time or maternal focus for the consent process to take place

Contacts and Locations

Principal Investigator

Mara Rosner, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

West Penn Hospital-Allegheny Health Network

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Mara Rosner, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-09

Study Completion Date2028-08

Study Record Updates

Study Start Date2022-08-09

Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

Umbilical Cord Clamping
Preterm Birth
Delayed Cord Clamping (DCC)

Additional Relevant MeSH Terms

Delayed Cord Clamping