Neuro Developmental DelayHRV ARTNCT00993369
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
An observational study of Neuro Developmental Delay, run by University of Utah at 1 site in United States.
Trial summary
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Neuro Developmental Delay
- What is being tested?
- Holter monitor
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2010
- Phase
- Observational
- 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 Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Study population: Fetus and newborns.
Who may be able to join
- Fetus or newborn
- Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center
Who cannot join
- Twins
- Genetic anomaly
- Congenital malformation
- Need for special care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Medical Center
Salt LakeCity, Utah, 84113
About this study
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.
Read the detailed description
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.
- Conditions
- Neuro Developmental Delay
- Being tested
- Holter monitor
- Keywords
- Prediction of neuro developmental delay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitorOther
Record heart rate for 2 to 6 hours on day of life 1 or 2.
| Study group | Role | What they receive |
|---|---|---|
| Healthy newborns conceived naturally | Not described Receives: Other: Holter monitor | |
| Healthy newborns conceived with IVF | Not described Receives: Other: Holter monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Holter monitor/2 aims
Measured: 2 to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro Developmental DelayStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993369
- Sponsor's protocol ID
- 00018811
- Acronym
- HRV ART
- Status last verified
- Nov 2016
- First submitted
- 8 Oct 2009
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
- ClinicalTrials.gov ID
- NCT00993369
- Acronym / sponsor ID
- HRV ART / 00018811
- Conditions
- Neuro Developmental Delay
- Keywords
- Prediction of neuro developmental delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Oct 2009 (estimated)
- 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.
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.
Detailed description
This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy newborns conceived naturally | – | Other: Holter monitor |
| Healthy newborns conceived with IVF | – | Other: Holter monitor |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fetus and newborns.
Key inclusion criteria (2 listed)
- Fetus or newborn
- Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center
Key exclusion criteria (4 listed)
- Twins
- Genetic anomaly
- Congenital malformation
- Need for special care
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 |
|---|---|---|
| Holter monitorRecord heart rate for 2 to 6 hours on day of life 1 or 2. | Other | Healthy newborns conceived naturally, Healthy newborns conceived with IVF |
Primary outcome
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies
Time frame: 2 to 6 hours
Holter monitor/2 aims
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro Developmental Delay, run by University of Utah 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies (time frame: 2 to 6 hours). 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 10 Nov 2016.