Lactic AcidemiaNCT05513690
Amnioinfusion for Intrauterine Neuroprotection
A study testing Amnioinfusion at room temperature (intervention arm) in people with Lactic Acidemia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactic Acidemia
- What is being tested?
- Amnioinfusion at room temperature (intervention arm)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal age >18 years old
- Singleton
- Term gestational age at time of admission (>37 weeks 0 days);
Who cannot join
- Major fetal anomaly
- Active substance or alcohol use
- Contraindications to intrauterine pressure catheter placement (e.g. placental previa, human immunodeficiency virus, Hepatitis C)
- Fetal growth restriction
- Inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Women and Infant's Hospital of Rhode Island
Providence, Rhode Island, 02905
Brock Polnaszek, MD
About this study
Official title: Amnioinfusion for Intrauterine Neuroprotection: A Pilot Randomized Controlled Trial
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.
Read the detailed description
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. In addition, maternal fever is associated with a four to five-fold increased risk of HIE. Two phases leading to HIE are recognized: neuronal death from cellular hypoxia and further injury from exhaustion of energy stores.
Therapeutic cooling of infants with HIE provides neuroprotection by reducing metabolic demands and suppressing toxic processes. Studies show that whole-body cooling of infants reduces the risk of neurologic motor and cognitive deficits with brain imaging suggesting that human infants who are cooled earlier have a greater benefit. Moreover, animal studies show that brain cooling may be more beneficial when given in utero at the time of an insult during the first phase of cellular hypoxia, rather than after delivery. Though therapeutic cooling in utero has yet to be explored in humans, an established in utero fluid delivery system-amnioinfusion- provides a unique opportunity for in utero intervention.
Amnioinfusion (AI), the administration of fluid via an intrauterine catheter inserted through the cervix, is a common intervention during labor to improve fetal heart tracings and reduce cesarean delivery. Introduced in 1983, it used warm saline due to a theoretical concern for fetal shock from cold fluids. Subsequent studies showed no advantage of warm fluids, and fluids at room temperature (~25oC) have become standard. AI can lower in utero temperature by 1.0°C (36.4°C versus 37.4°C, P<0.01). This 1.0°C degree of cooling has been associated a 6% reduction in brain energy utilization which could be protective against neurological injury. This suggests that AI can be leveraged to lower in utero and fetal temperatures to protect against neurologic injury.
Expanding the indication for AI is a novel approach to reduce neurologic injury in utero. However, there is a gap in the acceptability and efficacy of amnioinfusion for this indication. To fill this gap, we propose a pilot randomized controlled trial to test the feasibility and effects of amnioinfusion with fluids at room temperature on infants at high risk for neurologic injury including HIE.
- Conditions
- Lactic Acidemia
- Being tested
- Amnioinfusion at room temperature (intervention arm)
- Keywords
- Umbilical cord gases, Neonatal neurologic morbidity, Amnioinfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnioinfusion at room temperature (intervention arm)Procedure or surgery
Routine amnioinfusion and intrauterine temperature probe sensor
| Study group | Role | What they receive |
|---|---|---|
| Amnioinfusion at room temperature (intervention arm) | Experimental | 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. Receives: Procedure: Amnioinfusion at room temperature (intervention arm) |
| Standard of care (control arm) | No 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical artery lactate
Cord blood lactate at the time of delivery
Measured: Within 15 minutes of delivery
Secondary outcomes (5)
Number of eligible patients who consent to study
Number of patients approached and consented
Measured: Throughout study completion, an average of 1 year
Ottawa Decisional self-efficacy scale
The Decisional Self-Efficacy Scale measures self-confidence or belief in one's ability to make decisions, including participate in shared decision making will be compared between arms. The scale consists of 11 questions on a five-point Likert scale from 0 to 5. Scores range from 0 (not at all confident) to 100 (very confident). A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy.
Measured: Scale collected once from date of delivery following randomization until hospital discharge but within the first week
Labour Agentry Scale
Labour Agentry Scale, an instrument measuring expectancies and experiences of personal control during childbirth will be compared between arms. The Labour Agentry Scale consists of 29 short affirmative statements (e.g. 'I felt confident' and 'I felt tense'). Respondents were asked to rate each statement on a seven-point Likert scale from 1 (representing rarely) to 7 (representing almost always). Possible total scores for the Labour Agentry Scale range from 29 (indicating feelings of control rarely) to 203 (reflecting feelings of control almost always).
Measured: Scale collected once from date of delivery following randomization until hospital discharge but within the first week
Intrauterine temperature
Temperature of uterus
Measured: 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.
Neonatal core temperature
Core temperature
Measured: Within 10 minutes of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactic AcidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Amnioinfusion for intrapartum risk factors for neurologic morbidity versus no amnioinfusion.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Society of Maternal-Fetal Medicine
- Responsible party
- Sponsor
- Investigators
- Brock Polnaszek, MD, Principal investigator, Waren Alpert Medical School of Brown University, Women and Infant's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513690
- Sponsor's protocol ID
- WIHRI
- Status last verified
- Aug 2022
- First submitted
- 17 Jun 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnioinfusion for Intrauterine Neuroprotection: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05513690
- Acronym / sponsor ID
- WIHRI
- Conditions
- Lactic Acidemia
- Keywords
- Umbilical cord gases, Neonatal neurologic morbidity, Amnioinfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Foundation for Society of Maternal-Fetal Medicine
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. In addition, maternal fever is associated with a four to five-fold increased risk of HIE. Two phases leading to HIE are recognized: neuronal death from cellular hypoxia and further injury from exhaustion of energy stores.
Therapeutic cooling of infants with HIE provides neuroprotection by reducing metabolic demands and suppressing toxic processes. Studies show that whole-body cooling of infants reduces the risk of neurologic motor and cognitive deficits with brain imaging suggesting that human infants who are cooled earlier have a greater benefit. Moreover, animal studies show that brain cooling may be more beneficial when given in utero at the time of an insult during the first phase of cellular hypoxia, rather than after delivery. Though therapeutic cooling in utero has yet to be explored in humans, an established in utero fluid delivery system-amnioinfusion- provides a unique opportunity for in utero intervention.
Amnioinfusion (AI), the administration of fluid via an intrauterine catheter inserted through the cervix, is a common intervention during labor to improve fetal heart tracings and reduce cesarean delivery. Introduced in 1983, it used warm saline due to a theoretical concern for fetal shock from cold fluids. Subsequent studies showed no advantage of warm fluids, and fluids at room temperature (~25oC) have become standard. AI can lower in utero temperature by 1.0°C (36.4°C versus 37.4°C, P<0.01). This 1.0°C degree of cooling has been associated a 6% reduction in brain energy utilization which could be protective against neurological injury. This suggests that AI can be leveraged to lower in utero and fetal temperatures to protect against neurologic injury.
Expanding the indication for AI is a novel approach to reduce neurologic injury in utero. However, there is a gap in the acceptability and efficacy of amnioinfusion for this indication. To fill this gap, we propose a pilot randomized controlled trial to test the feasibility and effects of amnioinfusion with fluids at room temperature on infants at high risk for neurologic injury including HIE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Amnioinfusion for intrapartum risk factors for neurologic morbidity versus no amnioinfusion.
| Arm | Type | Receives |
|---|---|---|
| Amnioinfusion at room temperature (intervention arm) | Experimental | Procedure: Amnioinfusion at room temperature (intervention arm)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. |
| Standard of care (control arm) | No 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Maternal age >18 years old
- Singleton
- Term gestational age at time of admission (>37 weeks 0 days);
Key exclusion criteria (5 listed)
- Major fetal anomaly
- Active substance or alcohol use
- Contraindications to intrauterine pressure catheter placement (e.g. placental previa, human immunodeficiency virus, Hepatitis C)
- Fetal growth restriction
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnioinfusion at room temperature (intervention arm)Routine amnioinfusion and intrauterine temperature probe sensor | Procedure or surgery | Amnioinfusion at room temperature (intervention arm) |
Primary outcome
Umbilical artery lactate
Time frame: Within 15 minutes of delivery
Cord blood lactate at the time of delivery
5 secondary outcomes
Number of eligible patients who consent to study
Time frame: Throughout study completion, an average of 1 year
Ottawa Decisional self-efficacy scale
Time frame: Scale collected once from date of delivery following randomization until hospital discharge but within the first week
Labour Agentry Scale
Time frame: Scale collected once from date of delivery following randomization until hospital discharge but within the first week
Intrauterine temperature
Time frame: 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.
Neonatal core temperature
Time frame: Within 10 minutes of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brock Polnaszek, MD principal investigator
Waren Alpert Medical School of Brown University, Women and Infant's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnioinfusion at room temperature (intervention arm) in people with Lactic Acidemia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sue Elmore, MS,CRRP (401-274-1122 ext. 48675, selmore@carene.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical artery lactate (time frame: Within 15 minutes of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.