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| Name | Class |
|---|---|
| West Penn Allegheny Health System | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone Positioning | Procedure | Newborn will be prone position for 30-60 seconds during delayed umbilical cord clamping |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Katelyn Uribe, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| West Penn Hospital-Allegheny Health Network |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Supine Positioning | Procedure | Newborn will be supine position for 30-60 seconds during delayed umbilical cord clamping |
|
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| D000091642 | Urogenital Diseases |