Delayed Cord ClampingNCT05507424
Prone Positioning During Delayed Cord Clamping
A study testing Prone Positioning and Supine Positioning in people with Delayed Cord Clamping, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Delayed Cord Clamping
- What is being tested?
- Prone Positioning and Supine Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2022to Aug 2028
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
West Penn Hospital-Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Prone Positioning During Delayed Cord Clamping: A Randomized Control Pilot Study to Identify Optimal Neonatal Positioning During Delayed Cord Clamping
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.
Read the detailed description
This study is being done to see if placing babies on the stomach or the back during delayed cord clamping after birth will improve the outcomes of preterm babies. Studies have shown that in some instances, positioning on the belly may help newborns clear their respiratory secretions. Research has shown that preterm babies can have improved breathing and require less support when placed on the stomach (prone position) rather than the back (supine position). Currently there are no guidelines for the best position for neonates to be in while receiving delayed cord clamping. The investigators are hoping to complete a research study to determine if placing preterm babies on their stomachs during the time of delayed cord clamping will improve the breathing of preterm babies and reduce the need for additional oxygen support with a breathing tube (endotracheal intubation). Depending on the outcomes of the study, the investigators are hoping to determine which position results in better outcomes for babies in both the delivery room and in the neonatal intensive care unit. If the investigators are able to determine the optimal position in this study, the investigators hope to improve the outcomes for future babies that are born preterm by placing the baby in the optimal position during delayed cord clamping.
- Conditions
- Delayed Cord Clamping
- Being tested
- Prone Positioning, Supine Positioning
- Keywords
- Umbilical Cord Clamping, Preterm Birth, Delayed Cord Clamping (DCC)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningProcedure or surgery
Newborn will be prone position for 30-60 seconds during delayed umbilical cord clamping
Supine PositioningProcedure or surgery
Newborn will be supine position for 30-60 seconds during delayed umbilical cord clamping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Supine Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-60 seconds immediately after birth of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start9 Aug 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Cord ClampingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Responsible party
- Sponsor
- Investigators
- Katelyn Uribe, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507424
- Sponsor's protocol ID
- IRB00307467
- Status last verified
- Oct 2025
- First submitted
- 17 Aug 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning During Delayed Cord Clamping: A Randomized Control Pilot Study to Identify Optimal Neonatal Positioning During Delayed Cord Clamping
- ClinicalTrials.gov ID
- NCT05507424
- Acronym / sponsor ID
- IRB00307467
- Conditions
- Delayed Cord Clamping
- Keywords
- Umbilical Cord Clamping, Preterm Birth, Delayed Cord Clamping (DCC)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 19 Aug 2022 (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.
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.
Detailed description
This study is being done to see if placing babies on the stomach or the back during delayed cord clamping after birth will improve the outcomes of preterm babies. Studies have shown that in some instances, positioning on the belly may help newborns clear their respiratory secretions. Research has shown that preterm babies can have improved breathing and require less support when placed on the stomach (prone position) rather than the back (supine position). Currently there are no guidelines for the best position for neonates to be in while receiving delayed cord clamping. The investigators are hoping to complete a research study to determine if placing preterm babies on their stomachs during the time of delayed cord clamping will improve the breathing of preterm babies and reduce the need for additional oxygen support with a breathing tube (endotracheal intubation). Depending on the outcomes of the study, the investigators are hoping to determine which position results in better outcomes for babies in both the delivery room and in the neonatal intensive care unit. If the investigators are able to determine the optimal position in this study, the investigators hope to improve the outcomes for future babies that are born preterm by placing the baby in the optimal position during delayed cord clamping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Positioning During Delayed Cord Clamping | Active comparator | Procedure: Prone PositioningNewborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to prone positioning during routine delayed cord clamping. |
| Supine Positioning During Delayed Cord Clamping | Active comparator | Procedure: Supine PositioningNewborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to supine positioning during routine delayed cord clamping. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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:
- 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
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 |
|---|---|---|
| Prone PositioningNewborn will be prone position for 30-60 seconds during delayed umbilical cord clamping | Procedure or surgery | Prone Positioning During Delayed Cord Clamping |
| Supine PositioningNewborn will be supine position for 30-60 seconds during delayed umbilical cord clamping | Procedure or surgery | Supine Positioning During Delayed Cord Clamping |
Primary outcome
Number of pre-term neonates that require endotracheal intubation
Time frame: 30-60 seconds immediately after birth of the newborn
To determine if deliberate prone positioning of preterm neonates during delayed cord clamping reduces the need for endotracheal intubation in the delivery room.
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 3 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health
Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
Intact Cord Placental Delivery, Delayed Cord Clamping
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. This study is not recruiting at the moment.
Katelyn Uribe, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Positioning and Supine Positioning in people with Delayed Cord Clamping, run by Johns Hopkins University at 2 sites in United States.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pre-term neonates that require endotracheal intubation (time frame: 30-60 seconds immediately after birth of the newborn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.