PrematurityNCT01421238
Framing and Decision Making in Neonatology
A study testing Survey in people with Prematurity and Framing, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prematurity, Framing, Perinatal Decision Making
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 yo
Who cannot join
- <18 yo
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Center for Decision Sciences
New York, New York, 10027
About this study
Official title: Framing and Perinatal Decision Making at Extremes of Prematurity
The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions.
There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation.
The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.
- Conditions
- Prematurity, Framing, Perinatal Decision Making
- Being tested
- Survey
- Keywords
- Decision Making, Premature infant, Informed consent, Prematurity, Framing, Negotiation Model
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Participants were randomized to one of two survey groups. In one arm (resuscitation default arm), resuscitation was presented as the course of action that would be followed unless the participant objected. In the other arm (comfort care default arm), comfort care was presented as the course of action that would be followed unless the participant objected.
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation Default Arm | Experimental | After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information:
The doctor goes on to say that at this hospital infants born at 23 weeks will receive resuscitation, unless their parents object. If you decline resuscitation please check the box below:
Please check if you decline resuscitation [] Receives: Behavioral: Survey |
| Comfort Care Default Arm | Experimental | After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information:
The doctor goes on to say that at this hospital infants born at 23 weeks will receive comfort care, unless their parents object. If you decline comfort care please check the box below:
Please check if you decline comfort care [] Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants deciding to resuscitate an extremely premature infant.
Each participants decisional outcome (resuscitation or comfort care) per survey arm will be counted. We expect 60% of the participants will decide to resuscite in both arms. We expect that 90% will select resuscitation in those who receive the resuscitation default and 60% will select resuscitation in the comfort care default
Measured: Up to 1 year from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elke U. Weber, Columbia University
- Investigators
- Ryan Murphy, PhD, Principal investigator, Columbia UniversityElke U Weber, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421238
- Sponsor's protocol ID
- AAAB8193
- Status last verified
- Nov 2012
- First submitted
- 8 Aug 2011
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Haward MF, Murphy RO, Lorenz JM. Message framing and perinatal decisions. Pediatrics. 2008 Jul;122(1):109-18. doi: 10.1542/peds.2007-0620.
PubMed 18595993
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Framing and Perinatal Decision Making at Extremes of Prematurity
- ClinicalTrials.gov ID
- NCT01421238
- Acronym / sponsor ID
- AAAB8193
- Conditions
- Prematurity, Framing, Perinatal Decision Making
- Keywords
- Decision Making, Premature infant, Informed consent, Prematurity, Framing, Negotiation Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Aug 2011 (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.
The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions.
There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation.
The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation Default Arm | Experimental | Behavioral: SurveyAfter receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information: The doctor goes on to say that at this hospital infants born at 23 weeks will receive resuscitation, unless their parents object. If you decline resuscitation please check the box below: Please check if you decline resuscitation [] |
| Comfort Care Default Arm | Experimental | Behavioral: SurveyAfter receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information: The doctor goes on to say that at this hospital infants born at 23 weeks will receive comfort care, unless their parents object. If you decline comfort care please check the box below: Please check if you decline comfort care [] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 yo
Key exclusion criteria (1 listed)
- <18 yo
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 |
|---|---|---|
| SurveyParticipants were randomized to one of two survey groups. In one arm (resuscitation default arm), resuscitation was presented as the course of action that would be followed unless the participant objected. In the other arm (comfort care default arm), comfort care was presented as the course of action that would be followed unless the participant objected. | Behavioural | Comfort Care Default Arm, Resuscitation Default Arm |
Primary outcome
Number of participants deciding to resuscitate an extremely premature infant.
Time frame: Up to 1 year from the start of the study
Each participants decisional outcome (resuscitation or comfort care) per survey arm will be counted. We expect 60% of the participants will decide to resuscite in both arms. We expect that 90% will select resuscitation in those who receive the resuscitation default and 60% will select resuscitation in the comfort care default
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 22 Nov 2012.
- Results publication: PubMed 18595993Haward MF, Murphy RO, Lorenz JM. Message framing and perinatal decisions. Pediatrics. 2008 Jul;122(1):109-18. doi: 10.1542/peds.2007-0620.
Related trials for Prematurity
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Not yet recruitingObservational study
Probiotics in Preterm Babies Use & Abuse
Probiotic in Preterm Babies Use & Abuse, Uses
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
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.
Ryan Murphy, PhD principal investigator
Columbia University
Elke U Weber principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Prematurity and Framing, run by Columbia University 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 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 22 Nov 2012. 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?
Number of participants deciding to resuscitate an extremely premature infant. (time frame: Up to 1 year from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421238, which also lists 1 linked publication.
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 22 Nov 2012.