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Amnioinfusion for Intrauterine Neuroprotection

NCT05513690 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-08-29

No results posted yet for this study

Summary

Hypoxic ischemic encephalopathy (HIE), a serious brain injury in infants, occurs in 2-9 per 1,000 infants after delivery. Up to 60% of infants diagnosed with HIE die and 25% of the survivors have long-term neurologic deficits. Risk factors for HIE include abnormal fetal heart tracings and intrauterine infection. Therapeutic whole-body cooling of infants with HIE is standard of care after delivery, with only 7-9 at-risk infants needing to be treated to prevent one infant from suffering long-term neurologic deficits. However, animal studies show that therapeutic cooling may be more beneficial when given in utero at the time of an insult, rather than after delivery. Though therapeutic cooling in utero has yet to be explored in humans, an established in utero fluid delivery system during labor-amnioinfusion-provides a unique opportunity for in utero intervention. We propose a pilot randomized controlled trial to test the feasibility and preliminary effects of room temperature amnioinfusion on tissue injury including HIE.

Conditions

  • Lactic Acidemia

Interventions

PROCEDURE

Amnioinfusion at room temperature (intervention arm)

Routine amnioinfusion and intrauterine temperature probe sensor

Sponsors & Collaborators

  • Foundation for Society of Maternal-Fetal Medicine

    collaborator UNKNOWN

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Brock Polnaszek, MD · Waren Alpert Medical School of Brown University, Women and Infant's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-06-01
Completion
2024-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513690 on ClinicalTrials.gov