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Amnioinfusion for Birth-Related Brain Injury

N/A
Recruiting
Led By Brock Polnaszek, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maternal age >18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test the feasibility and preliminary effects of room temperature amnioinfusion on tissue injury including HIE, a serious brain injury in infants that can cause long-term neurologic deficits.

Who is the study for?
This trial is for pregnant individuals over 18 years old with a single baby at full term (over 37 weeks). It's not for those with major fetal anomalies, conditions that prevent safe monitoring during labor, HIV or Hepatitis C, inability to consent, babies not growing well in the womb, or active substance/alcohol use.Check my eligibility
What is being tested?
The study tests if amnioinfusion at room temperature can protect unborn babies' brains from injury when there's a risk of oxygen shortage. This pilot randomized controlled trial will compare standard care with and without this additional in utero intervention.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include discomfort from the procedure and risks associated with introducing fluid into the amniotic space. The safety profile will be closely monitored given it's an exploratory procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Structure of umbilical artery
Secondary outcome measures
Intrauterine temperature
Labour Agentry Scale
Neonatal core temperature
+2 more
Other outcome measures
Cardiotocography
Montevideo units
Number of patients with composite and individual maternal morbidity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amnioinfusion at room temperature (intervention arm)Experimental Treatment1 Intervention
Routine amnioinfusion will be administered via an intrauterine catheter inserted through the cervix. Normal saline at room temperature will be infused per hospital protocol at a rate of 600 milliliters/hour for the first hour followed by 180 milliliters/hour. A plastic applicator will be used to introduce a flexible disposable general-purpose temperature probe into the uterus. The probe will be guided to the contralateral side of the uterus from the intrauterine pressure catheter. Intrauterine temperature will then be measured by DataThermII continuous temperature monitor. This monitor has accuracy of 0.1 °C and will store temperature measurements every 10 minutes until delivery. The temperature data will be downloaded into a computer software. The DataThermII has been previously used in prior research to measure intrauterine temperature.
Group II: Standard of care (control arm)Active Control1 Intervention
Women in this group will have the temperature probe placed and temperate measured as described in experimental arm. They will otherwise receive current standard of care (i.e. no amnioinfusion).

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
108 Previous Clinical Trials
38,514 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

Media Library

Amnioinfusion at room temperature Clinical Trial Eligibility Overview. Trial Name: NCT05513690 — N/A
Lactic Acidemia Research Study Groups: Standard of care (control arm), Amnioinfusion at room temperature (intervention arm)
Lactic Acidemia Clinical Trial 2023: Amnioinfusion at room temperature Highlights & Side Effects. Trial Name: NCT05513690 — N/A
Amnioinfusion at room temperature 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513690 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of patients taking part in this medical experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical experiment was initially posted in June 15th 2022 and recently refreshed at the end of August 22nd 2022. 26 participants will be enrolled from a single location."

Answered by AI

Is this research endeavor currently enrolling participants?

"Affirmative. According to information published on clinicaltrials.gov, this medical experiment was initially posted in June 15th 2022 and recently updated on August 23rd of the same year. The study is currently searching for 26 participants from one specified location."

Answered by AI
~9 spots leftby Mar 2025