What side effects are associated with this type of intervention?

Common treatments for Lactic Acidemia include dietary management, supplements like thiamine or biotin, and in some cases, medications to reduce lactic acid levels. Side effects of these treatments can vary but may include gastrointestinal discomfort, allergic reactions, and potential nutrient imbalances. For treatments similar to room temperature amnioinfusion, such as therapeutic cooling, side effects could include infection risk, premature labor, or complications related to the cooling process itself. It is essential to discuss these potential risks with a healthcare provider.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Lactic Acidemia that are directly comparable to the concept of cooling in utero, as studied in the trial of Room Temperature Amnioinfusion. Lactic Acidemia is typically managed by addressing the underlying cause, supportive care, and sometimes using medications like dichloroacetate to reduce lactic acid levels. The innovative approach of cooling in utero for neuroprotection is still in the experimental stage and has not yet been applied to the treatment of Lactic Acidemia.

What other types of research exist?

For Lactic Acidemia patients, promising novel alternatives to Room Temperature Amnioinfusion include therapeutic whole-body cooling after delivery, which is the current standard of care for hypoxic ischemic encephalopathy (HIE). Additionally, selective cerebral hypothermia using a solid ice cap has shown potential in reducing neurological damage in neonates with HIE. These methods focus on neuroprotection and may offer benefits for managing tissue injury associated with Lactic Acidemia.

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Amnioinfusion for Birth-Related Brain Injury

N/A

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if introducing room temperature fluid into the womb during labor can help protect babies at high risk for serious brain injury by cooling them slightly before birth.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study completion, an average of 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Structure of umbilical artery

Secondary study objectives

Intrauterine temperature

Labour Agentry Scale

Neonatal core temperature

+2 more

Other study objectives

Cardiotocography

Montevideo units

Number of patients with composite and individual maternal morbidity

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lactic Acidemia treatments focus on reducing lactic acid levels and managing symptoms. Therapeutic hypothermia, which lowers the body's temperature, is used to decrease metabolic rate and oxygen demand, thereby reducing further tissue injury. This is crucial for conditions like hypoxic-ischemic encephalopathy (HIE), where cooling has been shown to improve outcomes by minimizing neurological damage. The idea of cooling in utero, as explored in room temperature amnioinfusion trials, aims to provide neuroprotection earlier, potentially offering greater benefits by intervening before significant injury occurs.

Acute symptomatic neonatal seizures, brain injury, and long-term outcome: The role of neuroprotective strategies.[Therapeutic advances in neonatology].[Treatment of encephalopathy by hypothermia in the term newborn].