Prone vs Supine Positioning for Delayed Cord Clamping

Not currently recruiting at 1 trial location

Overseen By Brittany Schwarz, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Triplet gestation, Major fetal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30-60 seconds

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best position for a newborn during delayed cord clamping, a technique where the baby remains connected to the umbilical cord briefly after birth to receive more oxygen and blood. Researchers aim to determine whether babies benefit more when placed on their stomach (prone positioning) or back (supine) during this process. Pregnant individuals expecting a preterm delivery between 25 and 29 weeks, without major fetal anomalies affecting breathing, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve outcomes for preterm infants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this technique is safe for newborns?

Research has shown that preterm babies can breathe better and need less assistance when placed on their stomachs (prone position) during delayed cord clamping. This practice involves keeping the baby connected to the umbilical cord for a short time after birth to receive more oxygen and blood. However, placing a baby on their stomach can sometimes cause problems, such as changes in blood flow or nerve issues, if not done correctly.

Delayed cord clamping itself is safe for mothers, as it does not increase the risk of heavy bleeding or the need for a blood transfusion. However, there might be a higher risk of jaundice (yellowing of the skin and eyes) with delayed cord clamping due to increased blood flow from the placenta.

Researchers are studying both stomach and back positions during delayed cord clamping to ensure they are safe and beneficial for newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring prone positioning during delayed cord clamping because it might improve health outcomes for preterm newborns. Delayed cord clamping is a standard practice that benefits newborns by increasing blood volume and improving iron stores. However, traditionally, this is done with the baby in a supine position. By investigating the prone position, researchers hope to discover if this can further enhance the benefits by possibly improving breathing and circulation right after birth. This trial could lead to a simple yet effective change in delivery room practices for vulnerable newborns.

What evidence suggests that prone positioning is effective for delayed cord clamping?

This trial will compare prone positioning with supine positioning during delayed cord clamping for newborns. Research has shown that preterm babies placed on their stomachs during delayed cord clamping can breathe better and need less assistance. However, a study with healthy newborns found no significant differences in blood levels, specifically in the amount of red blood cells, between babies held on their stomachs or backs. This suggests that while there are breathing benefits for preterm babies, the position might not significantly affect blood transfer. Overall, placing babies on their stomachs may aid breathing, but the benefits for blood transfer remain uncertain. ^{1 2 3 6 7}

Who Is on the Research Team?

Katelyn Uribe, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for newborns eligible for delayed cord clamping, with a gestational age of 25-29 weeks. It's open to single or twin pregnancies where the baby has no major anomalies or genetic conditions affecting breathing or need for intubation at birth. Mothers must understand and consent to the study.

Inclusion Criteria

I understand the study procedures and agree to participate.

I am pregnant and might deliver early due to my health condition.

Anticipated gestational age of delivery could be between 25w+0d - 29w+6d

Exclusion Criteria

Triplet or higher order gestation

Maternal or fetal/neonatal contraindication to delayed cord clamping

Acute maternal obstetric emergency that precludes time or maternal focus for the consent process to take place

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Newborns are positioned either prone or supine during delayed cord clamping for 30-60 seconds after birth

30-60 seconds

Follow-up

Participants are monitored for outcomes such as the need for endotracheal intubation and other respiratory support

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prone Positioning

Trial Overview The study is testing whether it's better for newborns to be on their back (supine) or belly (prone) during the first 30-60 seconds after birth when delayed cord clamping is performed, which allows maximum blood and oxygen transfer from placenta.

How Is the Trial Designed?

Group I: Prone Positioning During Delayed Cord Clamping Active Control 2 Interventions

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.

Group II: Supine Positioning During Delayed Cord Clamping Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

West Penn Allegheny Health System

Collaborator

Trials

36

Recruited

6,000+

Published Research Related to This Trial

Delayed cord clamping in preterm neonates significantly increases hematocrit levels at 4 hours after birth compared to early cord clamping, suggesting better blood volume and oxygen delivery.

The combination of delayed cord clamping and administration of ergometrine to the mother also resulted in higher temperatures, blood pressure, and urinary output in the neonates, indicating improved stability during the critical transition period after birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Delayed Cord Clamping on Hematocrit, and Thermal and Hemodynamic Stability in Preterm Neonates: A Randomized Controlled Trial. Dipak, NK., Nanavat, RN., Kabra, NK., et al.[2022]

Delayed cord clamping is beneficial for infants, but delaying it for too long (up to 50 minutes) can lead to serious health issues, as demonstrated in a case where an infant suffered from hypovolemic shock due to excessive blood loss into the placenta.

Medical guidelines recommend delaying cord clamping for only 30 seconds to 3 minutes, and this case highlights the risks of extending this practice beyond established recommendations, emphasizing the need to discourage extremely late cord clamping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Severe Infant-to-Placenta Hemorrhage in Association with Prolonged Delayed Cord Clamping. Svedenkrans, J., Aquilano, G., Pettersson, K.[2021]

Recent randomized controlled trials have shown that delayed cord clamping (2-3 minutes after birth) offers significant benefits for term infants, contrasting with the previously common practice of early cord clamping (within 15 seconds).

The review highlights the physiological mechanisms behind the advantages of delayed cord clamping, emphasizing its importance based on solid evidence from scientific societies and systematic reviews, which advocate for this practice in obstetrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of umbilical cord clamping of term infants. Ceriani Cernadas, JM.[2018]

In a study of four patients undergoing cervical spine surgery in the prone position, all experienced new neurologic deficits postoperatively, suggesting a potential risk associated with this positioning.

The deficits were linked to compromised spinal cord perfusion due to abdominal compression, highlighting the importance of using positioning frames and avoiding hypotension to maintain spinal cord health during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic deficits after cervical laminectomy in the prone position. Bhardwaj, A., Long, DM., Ducker, TB., et al.[2019]

Delaying cord clamping for at least 30-60 seconds after birth, while keeping the newborn at or below the level of the placenta, supports normal physiological processes and has demonstrated significant benefits for newborns.

Collaboration between the obstetric and neonatal teams, along with proper planning, can address practical challenges like thermoregulation, allowing neonatal nurses to play a crucial role in implementing this practice to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed cord clamping: a collaborative practice to improve outcomes. Scheans, P.[2013]

The implementation of a delayed cord-clamping protocol in 424 term neonates led to significantly higher mean transcutaneous bilirubin levels, indicating a potential short-term impact on neonatal jaundice.

Despite the increase in bilirubin levels and diagnoses of jaundice, there was no rise in the need for phototherapy, suggesting that while delayed cord clamping may affect bilirubin levels, it does not necessarily lead to more severe jaundice requiring treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of a Delayed Cord-Clamping Protocol With Hyperbilirubinemia in Term Neonates. Yang, S., Duffy, JY., Johnston, R., et al.[2021]

Inducing anesthesia in the prone position has been shown to be feasible and associated with very low complication rates, particularly in patients undergoing spinal surgery, according to recent literature including a randomized trial.

While prone induction may save time and reduce the risk of pressure injuries, there is currently insufficient evidence to recommend it as a routine practice due to potential airway management challenges and hemodynamic concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should we induce general anesthesia in the prone position? Ellard, L., Wong, DT.[2014]

Prone positioning during anesthesia is essential for many surgical procedures, but it leads to predictable physiological changes and potential complications that need to be understood for safe use.

The review aims to highlight the risks of prone positioning and offers strategies to anticipate and minimize these risks, ensuring better outcomes for patients undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthesia in the prone position. Edgcombe, H., Carter, K., Yarrow, S.[2022]

A randomized trial involving healthy newborns showed no significant difference in hematocrit levels at 30 hours of life between those positioned prone or supine during delayed cord clamping, with mean values of 52 and 53.1, respectively.

Both positioning methods resulted in comparable cerebral tissue oxygenation levels, indicating that the choice of position may not impact these critical health markers immediately after birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supine versus Prone Position during Delayed Cord Clamping in Infants ≥36 Weeks: A Randomized Trial. Bensouda, B., Mandel, R., Mejri, A., et al.[2023]

The study measured cervical epidural pressure (CEP) in 30 subjects, finding that CEP was significantly higher in the prone position (median 10 mmHg) compared to the sitting position (median -0.3 mmHg), indicating a notable difference based on body position.

The results suggest that the hanging drop technique, which relies on the assumption of negative pressure in the epidural space, is inappropriate for identifying the cervical epidural space, as CEPs were not consistently negative even in the sitting position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical epidural pressure measurement: comparison in the prone and sitting positions. Moon, JY., Lee, PB., Nahm, FS., et al.[2017]

CPR in the prone position is a viable alternative to traditional supine CPR, especially when the airway is secured, as supported by a systematic review of 52 studies.

Defibrillation can also be effectively performed in the prone position, highlighting the importance of training healthcare providers in these techniques to improve outcomes during emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Resuscitation in the Prone Position in the Operating Room or in the Intensive Care Unit: A Systematic Review. Anez, C., Becerra-Bolaños, Á., Vives-Lopez, A., et al.[2023]

The article emphasizes the importance of prone positioning in optimizing exposure during certain surgical procedures, highlighting its potential benefits for patient outcomes.

It provides a safe and efficient method for placing patients in the prone position, addressing the lack of empirical studies on this topic and following established moving and handling principles to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prone positioning made easy. Craig, K.[2019]

In a study of 750 patients undergoing cervical spine surgery, the sitting position was associated with significantly lower odds of developing any complications compared to the prone position, suggesting it may be a safer option for certain procedures.

Despite longer anesthetic and operative times in the sitting position, the rates of 30-day readmission and reoperation were similar between the two positions, indicating that the sitting position can be as safe as the prone position for these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in single-level posterior cervical spine surgeries performed in the sitting and prone positions. Himes, BT., Abcejo, AS., Kerezoudis, P., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05507424

Prone Positioning During Delayed Cord Clamping 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 ( ...

2. withpower.com withpower.com/trial/phase-delayed-cord-clamping-7-2022-585b0

Prone vs Supine Positioning for Delayed Cord Clamping A randomized trial involving healthy newborns showed no significant difference in hematocrit levels at 30 hours of life between those positioned prone or supine ...

3. clinconnect.io clinconnect.io/trials/NCT05507424

Prone Positioning During Delayed Cord Clamping - ClinConnect This clinical trial is studying the best position for newborns during a procedure called delayed cord clamping, which happens right after birth. Delayed cord ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596201/

Evidence reviews for position of the baby during cord clamping The aim of this review is to assess whether there is a difference in outcomes for babies held at or below vaginal level or at the mother's abdominal or chest ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5400681/

Evaluation of Introduction of a Delayed Cord Clamping ... Compared to historical controls, performing delayed cord clamping in eligible preterm infants was associated with improved neonatal hematologic indices, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05507424?cond=(GAZE%20PALSY,%20FAMILIAL%20HORIZONTAL,%20WITH%20PROGRESSIVE%20SCOLIOSIS%202,%20WITH%20IMPAIRED%20INTELLECTUAL%20DEVELOPMENT)%20OR%20(DCC)&rank=5

Prone Positioning During Delayed Cord Clamping | ... 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 ( ...

7. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/12/delayed-umbilical-cord-clamping-after-birth

Delayed Umbilical Cord Clamping After Birth In terms of maternal outcomes, delayed umbilical cord clamping does not increase the risk of postpartum hemorrhage or the need for blood transfusion.