Effect NeonatalPhase 3NCT05304598
Using Dexmedetomidine Prior to Intubation in Neonates
A Phase 3 study testing Dexmedetomidine in people with Effect Neonatal, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including… Read more about this study
- Who is it for?
- Ages 0 to 120 daysHealthy volunteers can take part
- Conditions the study is for
- Effect Neonatal
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 20 Aug 2024
- Phase
- Phase 3
- 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 0 to 120 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neonates
- elective intubation
- admitted to the NICU
- Less than 44 weeks corrected gestational age requiring intubation
Who cannot join
- babies requiring emergent intubation
- Neonates with birth weight<1250 grams and <1 week of postnatal age
- Neonates with major congenital malformations
- Neonates with preexisting hypotension (MAP < Gest Age)
- Neonates with complex congenital heart disease and heart block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates
Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates.
This study will compare the efficacy of a single dose of dexmedetomidine to controls.
Read the detailed description
This is an interventional un-blinded, randomized, prospective pilot study to examine the efficacy of dexmedetomidine in reducing time to intubation, pain/discomfort associated with intubation and maintaining better oxygen saturations in neonates during intubation. The study will be done in the Neonatal Intensive Care Unit at Maimonides Medical Center.
Parents of babies requiring intubation will be approached by the Neonatal attending / fellow to obtain consent for the study. If a consent is obtained, babies will be randomized to a control or study group. Babies in the control group will undergo routine intubation by a neonatologist but with monitoring of the vital signs, those in the study group will receive the study drug 10 minutes prior to intubation.
Data Collection Procedures:
The research data will reside in an encrypted laptop issued by MIS that is housed in the Division of Newborn Medicine, within the medical center.
The data will be accessible to all researchers. If needed, de-identified data will be stored/shared on the Maimonides share point website for statistical and backup purposes.
The data that will be collected are heart rate, respiratory rate, oxygen saturation, measured continuously, and blood pressure measurement every five minutes. Data will be collected 15 minutes before, during and 30 minutes after intubation.
- Conditions
- Effect Neonatal
- Being tested
- Dexmedetomidine, Usual Care
- Keywords
- sedation, intubation, neonates, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Usual CareOther
routine awake intubation as per current unit standard of care,
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes Receives: Drug: Dexmedetomidine |
| Control Group | Active comparator | routine awake intubation as per current unit standard of care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation Differences
Compare oxygen saturation differences between the control and study group
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Mar 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Why it stopped: Not able to recruit patients due to lack of consent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect NeonatalStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alok Bhutada, Maimonides Medical Center
- Investigators
- Alok Bhutada, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304598
- Sponsor's protocol ID
- 2021-03-05
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates
- ClinicalTrials.gov ID
- NCT05304598
- Acronym / sponsor ID
- 2021-03-05
- Conditions
- Effect Neonatal
- Keywords
- sedation, intubation, neonates, dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit patients due to lack of consent.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 31 Mar 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.
Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates.
This study will compare the efficacy of a single dose of dexmedetomidine to controls.
Detailed description
This is an interventional un-blinded, randomized, prospective pilot study to examine the efficacy of dexmedetomidine in reducing time to intubation, pain/discomfort associated with intubation and maintaining better oxygen saturations in neonates during intubation. The study will be done in the Neonatal Intensive Care Unit at Maimonides Medical Center.
Parents of babies requiring intubation will be approached by the Neonatal attending / fellow to obtain consent for the study. If a consent is obtained, babies will be randomized to a control or study group. Babies in the control group will undergo routine intubation by a neonatologist but with monitoring of the vital signs, those in the study group will receive the study drug 10 minutes prior to intubation.
Data Collection Procedures:
The research data will reside in an encrypted laptop issued by MIS that is housed in the Division of Newborn Medicine, within the medical center.
The data will be accessible to all researchers. If needed, de-identified data will be stored/shared on the Maimonides share point website for statistical and backup purposes.
The data that will be collected are heart rate, respiratory rate, oxygen saturation, measured continuously, and blood pressure measurement every five minutes. Data will be collected 15 minutes before, during and 30 minutes after intubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Dexmedetomidinea single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes |
| Control Group | Active comparator | Other: Usual Careroutine awake intubation as per current unit standard of care |
Who may qualify
- Ages
- 0 to 120 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- neonates
- elective intubation
- admitted to the NICU
- Less than 44 weeks corrected gestational age requiring intubation
Key exclusion criteria (5 listed)
- babies requiring emergent intubation
- Neonates with birth weight<1250 grams and <1 week of postnatal age
- Neonates with major congenital malformations
- Neonates with preexisting hypotension (MAP < Gest Age)
- Neonates with complex congenital heart disease and heart block
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 |
|---|---|---|
| Dexmedetomidinea single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes | Drug | Dexmedetomidine Group |
| Usual Careroutine awake intubation as per current unit standard of care, | Other | Control Group |
Primary outcome
Oxygen Saturation Differences
Time frame: 30 minutes
Compare oxygen saturation differences between the control and study group
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alok Bhutada principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Effect Neonatal, run by Maimonides Medical Center 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 4 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: withdrawn, as of the sponsor's last update on 28 Mar 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation Differences (time frame: 30 minutes). 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 28 Mar 2025.