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Q&A

Neonatology

Poster Session 1

(286) Amnioinfusion for intrauterine neuroprotection: A pilot randomized feasibility trial

Tuesday, February 13, 2024

10:30 AM – 12:00 PM

Location: Prince George's Exhibit Hall CDE, Lower Atrium Level

Primary & Presenting Author(s)

Brock E. Polnaszek, MD

Maternal Fetal Medicine Fellow
Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States

Coauthor(s)

JR

Julia Rossen, BA

Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States
Lauren M. Murphy, MD

Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States
Anna Whelan, MD (she/her/hers)

University of Massachusetts Chan Medical School
Grafton, MA, United States
MH

Maureen Hamel, MD

Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States
Dwight J. Rouse, MD, MSPH

Professor
Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States
Methodius G. Tuuli, MBA, MD, MPH

Chace-Joukowsky Professor and Chair
Women & Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University
Providence, RI, United States
Adam K. Lewkowitz, MD, MPH

Assistant Professor
Warren Alpert Medical School of Brown University, Women & Infants Hospital Rhode Island
Providence, RI, United States

Objective: Amnioinfusion (AI) has the potential to reduce neurologic injury in at risk fetuses via in-utero hypothermia. We performed a pilot randomized controlled trial to assess the feasibility and effects of AI with room-temperature fluid in such fetuses.

Study Design: Participants in labor with term singleton pregnancies who developed risk factors for fetal neurologic injury (chorioamnionitis or Category 2 fetal heart tracing) underwent intrauterine pressure catheter placement and randomization to continuous AI of room-temperature fluid or no AI until delivery. Intrauterine temperature (IUT) was monitored with a temperature probe (DataTherm II, Medline). The primary outcome was umbilical artery lactate (UAL). Secondary outcomes included neonatal core temperature within 10 minutes of birth, IUT at 10 minute intervals, composite maternal and neonatal morbidity, decisional self-efficacy and labour agentry scores. To detect a 50% difference in UAL (similar to fetal morbidity data from intrauterine ischemia), 13 participants were needed in both groups (2-tailed test, alpha 0.5, 10% attrition). Analysis was by intention-to-treat. ClinicalTrials.gov Identifier: NCT05513690

Results: Of 226 women approached, 85 (37.6%) were consented with 26 randomized. At baseline, the study groups were similar. UAL did not significantly differ between the AI (median [interquartile range] 5.1 [4.5-7] mmol/L) and no AI group (4.4 [3.6-5.6] mmol/L; p=0.18). IUT, neonatal core temperature, and composite maternal and neonatal morbidity did not significantly differ. Decisional self-efficacy and labour agentry scores were similarly high between groups.

Conclusion: Continuous AI with room-temperature fluid in fetuses at risk for neurologic injury is feasible but did not lower neonatal core temperature or UAL. Future research should examine whether AI with cold-fluid will achieve in-utero hypothermia and reduce neurologic injury.