NCT05507424

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Aug 2022Aug 2028

Study Start

First participant enrolled

August 9, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

6 years

First QC Date

August 17, 2022

Last Update Submit

October 2, 2025

Conditions

Delayed Cord Clamping

Keywords

Umbilical Cord ClampingPreterm BirthDelayed Cord Clamping (DCC)

Outcome Measures

Primary Outcomes (1)

  • Number of pre-term neonates that require endotracheal intubation

    To determine if deliberate prone positioning of preterm neonates during delayed cord clamping reduces the need for endotracheal intubation in the delivery room.

    30-60 seconds immediately after birth of the newborn

Study Arms (2)

Prone Positioning During Delayed Cord Clamping

ACTIVE COMPARATOR

Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to prone positioning during routine delayed cord clamping.

Procedure: Prone Positioning

Supine Positioning During Delayed Cord Clamping

ACTIVE COMPARATOR

Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to supine positioning during routine delayed cord clamping.

Procedure: Supine Positioning

Interventions

Prone PositioningPROCEDURE

Newborn will be prone position for 30-60 seconds during delayed umbilical cord clamping

Prone Positioning During Delayed Cord Clamping
Supine PositioningPROCEDURE

Newborn will be supine position for 30-60 seconds during delayed umbilical cord clamping

Supine Positioning During Delayed Cord Clamping

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

West Penn Hospital-Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katelyn Uribe, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 19, 2022

Study Start

August 9, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

October 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)