Amnioinfusion at room temperature (intervention arm) for Lactic Acidemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Women and Infant's Hospital of Rhode Island, Providence, RI
Lactic Acidemia
Amnioinfusion at room temperature (intervention arm) - Procedure
Eligibility
18+
Female
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Throughout study completion, an average of 1 year

10-minute intervals from date/time of randomization until date/time of delivery, assessed only until fetus is delivered or end of second stage of labor.
Electronic fetal monitoring
Intrauterine temperature
Montevideo units
Week 6
Number of patients with composite and individual maternal morbidity
Number of patients with composite and individual neonatal morbidity
Week 6
Number of patients with placental pathology available
Scale collected once from date of delivery following randomization until hospital discharge but within the first week
Labour Agentry Scale
Ottawa Decisional self-efficacy scale
Year 1
Number of eligible patients who consent to study
Within 10 minutes of birth
Neonatal core temperature
Within 15 minutes of delivery
Umbilical artery lactate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of care (control arm)
1 of 2
Amnioinfusion at room temperature (intervention arm)
1 of 2
Active Control
Experimental Treatment

26 Total Participants · 2 Treatment Groups

Primary Treatment: Amnioinfusion at room temperature (intervention arm) · No Placebo Group · N/A

Amnioinfusion at room temperature (intervention arm)
Procedure
Experimental Group · 1 Intervention: Amnioinfusion at room temperature (intervention arm) · Intervention Types: Procedure
Standard of care (control arm)NoIntervention Group · 1 Intervention: Standard of care (control arm) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout study completion, an average of 1 year
Closest Location: Women and Infant's Hospital of Rhode Island · Providence, RI
Photo of rhode island 1Photo of rhode island 2Photo of rhode island 3
2018First Recorded Clinical Trial
1 TrialsResearching Lactic Acidemia
1 CompletedClinical Trials

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
96 Previous Clinical Trials
33,814 Total Patients Enrolled
Foundation for Society of Maternal-Fetal MedicineUNKNOWN
Brock Polnaszek, MDPrincipal InvestigatorWaren Alpert Medical School of Brown University, Women and Infant's Hospital

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a singleton pregnancy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.