Extreme PrematurityPreCo-parentsNCT02782637
Prenatal Counseling in Extreme Prematurity: Parents' View
An observational study of Extreme Prematurity and Complications, run by Radboud University Medical Center.
Trial summary
This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and neonatologists, as well as parents' views on this. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Extreme Prematurity, Complications
- What is being tested?
- survey and interview
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of the cohort 01-10-2010 to 01-10-2013 of parents who were confronted with the birth of an extremely preterm infant with a gestational age between 24 and 25 weeks, after the introduction of the new Dutch guideline in October 2010.
Who may be able to join
- The study population consists of the cohort 01-10-2010 to 01-10-2013 of parents who were confronted with the birth of an extremely preterm infant with a gestational age between 24 and 25 weeks, after the introduction of the new Dutch guideline in October 2010.
Who cannot join
- birth at 24-25 weeks of gestation due to active termination of pregnancy
About this study
This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and neonatologists, as well as parents' views on this.
Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with parental consent) but as some international guidelines, the Dutch guideline lacks detailed recommendations on organization, content and preferred decision-making of the counselling.
Read the detailed description
The anticipated delivery of an infant at the limits of viability presents parents and professionals with medical, ethical and emotional issues; especially when a decision on the initiation of care has to be made. Since the first publication in 2002 by the American Academy of Pediatrics several (albeit different) guidelines and recommendations on periviability counseling have been published. However, there is no universally accepted way of performing prenatal counseling and, consequently, studies describe heterogeneous counseling practices worldwide.
Some guidelines on resuscitation at the limits of viability include recommendations on the parental involvement in the decision-making. Nevertheless, the extent of involvement and the gestational age (GA) at which parents should be involved varies. In 2010, the Dutch guideline on perinatal practice in extremely premature delivery lowered the limit offering intensive care from 25+0 to 24+0 weeks GA. Just as some international guidelines include a role for parents at the limits of viability, the Dutch guideline states that at 24 weeks GA informed consent of parents is required when initiating intensive care28. Although the guideline acknowledges the importance of prenatal counseling, recommendations on organization, content or decision-making of the counseling are very limited.
Although recommendations on counseling do exist, they may not be generally applicable in the Netherlands since cross-cultural differences in perinatal practices, healthcare organization, and physician and patient views are likely to exist. To compose a national framework on prenatal counseling at the limits of viability, the nationwide PreCo study (Prenatal Counseling in Prematurity) was designed, examining both professional and parental views. High quality of care originates when no differences exist between preferred and current counseling with uniformity between the involved caregivers (obstetricians and neonatologists) and specified to the needs of those receiving counseling, being the parents The PreCo study amongst parents has three major aims
- to find initial preferences among Dutch experienced parents on prenatal counseling at the limits of viability (quantitatively)
- to evaluate decision-making among Dutch experienced parents at the limits of viability (quantitatively)
- to perform in-depth exploration of counseling preferences amongst Dutch parents (qualitatively)
- Conditions
- Extreme Prematurity, Complications
- Being tested
- survey and interview
- Keywords
- limits of viability, Prenatal Counseling, Decision-making, Viability, Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey and interviewOther
all participants: survey on prenatal counseling and treatment decisions at the limits of viability.
a selection of participants: individual interviews to further perform in-depth exploration of prenatal counseling preferences
| Study group | Role | What they receive |
|---|---|---|
| Survey and interviews | *part one* (quantitative)
Survey on:
A. prenatal counseling at the limits of viability, within three domains of interest:
* organization of prenatal counseling
* content of prenatal counseling
* decision-making in prenatal counseling Domains used to evaluate current counseling and counseling preferences
B. decision-making at the limits of viability: evaluation of the made decision (decisional conflict and regret)
*part two* (qualitative)
Individual interviews (qualitative) to in-depth explore preferences in prenatal counseling
* insight in the specific preferred content of prenatal counseling.
* study influencing factors on preferences in the domains of organization and decision-making. Receives: Other: survey and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)
Measured: during the time of the survey (march 2015 - march 2016)
evaluation of the decision made (decisional conflict and regret)
Measured: during the time of the survey (march 2015 - march 2016)
qualitative explored specific preferences in content, influencing factors on organization and decision-making
Measured: during the interviews (may - june 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme PrematurityStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, Leiden University Medical Center, Erasmus Medical Center, Maastricht universitair medisch centrum, Maastricht, Isala, University Medical Center Groningen, Maxima Medical Center, Amsterdam UMC, location VUmc, Fonds NutsOhra
- Responsible party
- Sponsor
- Investigators
- Marije Hogeveen, MD, PhD, Principal investigator, Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782637
- Sponsor's protocol ID
- Preco-2
- Acronym
- PreCo-parents
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Counseling in Extreme Prematurity: Parents' View
- ClinicalTrials.gov ID
- NCT02782637
- Acronym / sponsor ID
- PreCo-parents / Preco-2
- Conditions
- Extreme Prematurity, Complications
- Keywords
- limits of viability, Prenatal Counseling, Decision-making, Viability, Counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, Leiden University Medical Center, Erasmus Medical Center, Maastricht universitair medisch centrum, Maastricht, Isala, University Medical Center Groningen, Maxima Medical Center, Amsterdam UMC, location VUmc, Fonds NutsOhra
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 May 2016 (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 study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and neonatologists, as well as parents' views on this.
Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with parental consent) but as some international guidelines, the Dutch guideline lacks detailed recommendations on organization, content and preferred decision-making of the counselling.
Detailed description
The anticipated delivery of an infant at the limits of viability presents parents and professionals with medical, ethical and emotional issues; especially when a decision on the initiation of care has to be made. Since the first publication in 2002 by the American Academy of Pediatrics several (albeit different) guidelines and recommendations on periviability counseling have been published. However, there is no universally accepted way of performing prenatal counseling and, consequently, studies describe heterogeneous counseling practices worldwide.
Some guidelines on resuscitation at the limits of viability include recommendations on the parental involvement in the decision-making. Nevertheless, the extent of involvement and the gestational age (GA) at which parents should be involved varies. In 2010, the Dutch guideline on perinatal practice in extremely premature delivery lowered the limit offering intensive care from 25+0 to 24+0 weeks GA. Just as some international guidelines include a role for parents at the limits of viability, the Dutch guideline states that at 24 weeks GA informed consent of parents is required when initiating intensive care28. Although the guideline acknowledges the importance of prenatal counseling, recommendations on organization, content or decision-making of the counseling are very limited.
Although recommendations on counseling do exist, they may not be generally applicable in the Netherlands since cross-cultural differences in perinatal practices, healthcare organization, and physician and patient views are likely to exist. To compose a national framework on prenatal counseling at the limits of viability, the nationwide PreCo study (Prenatal Counseling in Prematurity) was designed, examining both professional and parental views. High quality of care originates when no differences exist between preferred and current counseling with uniformity between the involved caregivers (obstetricians and neonatologists) and specified to the needs of those receiving counseling, being the parents The PreCo study amongst parents has three major aims
- to find initial preferences among Dutch experienced parents on prenatal counseling at the limits of viability (quantitatively)
- to evaluate decision-making among Dutch experienced parents at the limits of viability (quantitatively)
- to perform in-depth exploration of counseling preferences amongst Dutch parents (qualitatively)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey and interviews | – | Other: survey and interview*part one* (quantitative) Survey on: A. prenatal counseling at the limits of viability, within three domains of interest: * organization of prenatal counseling * content of prenatal counseling * decision-making in prenatal counseling Domains used to evaluate current counseling and counseling preferences B. decision-making at the limits of viability: evaluation of the made decision (decisional conflict and regret) *part two* (qualitative) Individual interviews (qualitative) to in-depth explore preferences in prenatal counseling * insight in the specific preferred content of prenatal counseling. * study influencing factors on preferences in the domains of organization and decision-making. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of the cohort 01-10-2010 to 01-10-2013 of parents who were confronted with the birth of an extremely preterm infant with a gestational age between 24 and 25 weeks, after the introduction of the new Dutch guideline in October 2010.
Key inclusion criteria (1 listed)
- The study population consists of the cohort 01-10-2010 to 01-10-2013 of parents who were confronted with the birth of an extremely preterm infant with a gestational age between 24 and 25 weeks, after the introduction of the new Dutch guideline in October 2010.
Key exclusion criteria (1 listed)
- birth at 24-25 weeks of gestation due to active termination of pregnancy
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 |
|---|---|---|
| survey and interviewall participants: survey on prenatal counseling and treatment decisions at the limits of viability. a selection of participants: individual interviews to further perform in-depth exploration of prenatal counseling preferences | Other | Survey and interviews |
Primary outcome
current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)
Time frame: during the time of the survey (march 2015 - march 2016)
evaluation of the decision made (decisional conflict and regret)
Time frame: during the time of the survey (march 2015 - march 2016)
qualitative explored specific preferences in content, influencing factors on organization and decision-making
Time frame: during the interviews (may - june 2015)
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 25 May 2016.
Related trials for Extreme Prematurity
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
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.
Marije Hogeveen, MD, PhD principal investigator
Radboud
Questions about this trial
What is this clinical trial studying?
An observational study of Extreme Prematurity and Complications, run by Radboud University Medical Center.
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 1 inclusion and 1 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making) (time frame: during the time of the survey (march 2015 - march 2016)). The study lists 3 primary outcomes in all. 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 25 May 2016.