Prone vs Supine Positioning for Delayed Cord Clamping

Recruiting at1 trial location

Overseen by Mara Rosner, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Triplet gestation, Major fetal anomaly, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether preterm babies should lie on their back or belly during delayed cord clamping right after birth. Delayed cord clamping means waiting a short time before cutting the umbilical cord to give the baby more blood and oxygen. The study aims to see if lying on the belly helps these babies breathe better and need less extra oxygen. Delayed umbilical cord clamping is associated with greater haemoglobin concentration and iron storage in the first few months of life and with less need of blood transfusion and lower incidence of neonatal hypotension compared to early umbilical cord clamping.

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 data supports the effectiveness of the treatment Prone Positioning during Delayed Cord Clamping?

The research suggests that prone positioning on the mother's chest during delayed cord clamping may lead to a higher hematocrit (a measure of the proportion of red blood cells in the blood) at 30 hours of life compared to supine positioning, which could indicate better blood volume and oxygen delivery in newborns. ^{1 2 3 4 5}

Is prone positioning generally safe for humans?

Prone positioning is used in various surgeries and can be safe if done correctly, but it may lead to complications like changes in blood flow and nerve issues. Proper techniques and precautions can help minimize these risks. ^{3 6 7 8 9}

How does the treatment of prone positioning during delayed cord clamping differ from other treatments?

Prone positioning during delayed cord clamping involves placing the newborn on the mother's chest face down, which may lead to higher blood levels at 30 hours of life compared to the traditional supine (face up) position. This approach is unique as it explores the impact of newborn positioning on the benefits of delayed cord clamping, which is a practice that allows more blood to transfer from the placenta to the baby after birth. ^{1 10 11 12 13}

Research Team

Mara Rosner, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Prone Positioning (Behavioural Intervention)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

West Penn Allegheny Health System

Collaborator

Trials

36

Recruited

6,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supine versus Prone Position during Delayed Cord Clamping in Infants ≥36 Weeks: A Randomized Trial. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Effect of Delayed Cord Clamping on Hematocrit, and Thermal and Hemodynamic Stability in Preterm Neonates: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Neurologic deficits after cervical laminectomy in the prone position. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Association of a Delayed Cord-Clamping Protocol With Hyperbilirubinemia in Term Neonates. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cervical epidural pressure measurement: comparison in the prone and sitting positions. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Should we induce general anesthesia in the prone position? [2014]

7. England pubmed.ncbi.nlm.nih.gov

Anaesthesia in the prone position. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prone positioning made easy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes in single-level posterior cervical spine surgeries performed in the sitting and prone positions. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

A Case of Severe Infant-to-Placenta Hemorrhage in Association with Prolonged Delayed Cord Clamping. [2021]

12. Argentina pubmed.ncbi.nlm.nih.gov

Timing of umbilical cord clamping of term infants. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Resuscitation in the Prone Position in the Operating Room or in the Intensive Care Unit: A Systematic Review. [2023]