Extreme PrematurityNCT04074525
Evaluating Decisional Regret Among Mothers
An observational study of Extreme Prematurity and Birth, Preterm, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Extreme Prematurity, Birth, Preterm, Pregnancy Preterm
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 30 Jun 2021
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: The study population will consist of mothers who delivered infants between 22 and 25 completed weeks gestation during the study timeframe at one of two US perinatal centers.
Who may be able to join
- Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe.
- Mothers who had a documented perinatal consult
- Greater than 18 years old
Who cannot join
- Potential life limiting fetal diagnoses aside from prematurity and non-English primary language
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
About this study
Official title: Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.
- Conditions
- Extreme Prematurity, Birth, Preterm, Pregnancy Preterm
- Keywords
- Decisional regret, Comfort care, Palliative care, Infant resuscitation
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional regret
To assess decisional regret in mothers of extremely premature liveborn infants.
Measured: Within the last 14 years
Comparison of decisional regret
Comparison of decisional regret in mothers who chose resuscitation versus mothers who chose comfort care at the time of delivery.
Measured: Within the last 14 years
Secondary outcomes (1)
Define characteristics associated with decisional regret
Identify characteristics, and specifically potentially modifiable characteristics, that are associated with decisional regret in our population of mothers.
Measured: Within the last 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start24 Mar 2020
- Primary completion30 May 2021
- Study completion30 Jun 2021
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 Extreme PrematurityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Sponsor
- Investigators
- Laura Belden, DO, Principal investigator, Christiana Care Health Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074525
- Sponsor's protocol ID
- DDD604440
- Status last verified
- Jul 2021
- First submitted
- 28 Aug 2019
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belden L, Kaempf J, Mackley A, Kernan-Schloss F, Chen C, Sturtz W, Tomlinson MW, Guillen U. Evaluating decision regret after extremely preterm birth. Arch Dis Child Fetal Neonatal Ed. 2025 Feb 21;110(2):191-199. doi: 10.1136/archdischild-2024-327287.
PubMed 39164062
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret
- ClinicalTrials.gov ID
- NCT04074525
- Acronym / sponsor ID
- DDD604440
- Conditions
- Extreme Prematurity, Birth, Preterm, Pregnancy Preterm
- Keywords
- Decisional regret, Comfort care, Palliative care, Infant resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 Aug 2019 (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.
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of mothers who delivered infants between 22 and 25 completed weeks gestation during the study timeframe at one of two US perinatal centers.
Key inclusion criteria (3 listed)
- Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe.
- Mothers who had a documented perinatal consult
- Greater than 18 years old
Key exclusion criteria (1 listed)
- Potential life limiting fetal diagnoses aside from prematurity and non-English primary language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decisional regret
Time frame: Within the last 14 years
To assess decisional regret in mothers of extremely premature liveborn infants.
Comparison of decisional regret
Time frame: Within the last 14 years
Comparison of decisional regret in mothers who chose resuscitation versus mothers who chose comfort care at the time of delivery.
1 secondary outcome
Define characteristics associated with decisional regret
Time frame: Within the last 14 years
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 8 Jul 2021.
- Derived from this study: PubMed 39164062Belden L, Kaempf J, Mackley A, Kernan-Schloss F, Chen C, Sturtz W, Tomlinson MW, Guillen U. Evaluating decision regret after extremely preterm birth. Arch Dis Child Fetal Neonatal Ed. 2025 Feb 21;110(2):191-199. doi: 10.1136/archdischild-2024-327287.
- Individual participant dataSharing planned: No
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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.
Laura Belden, DO principal investigator
Christiana Care Health Services, Inc.
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 Extreme Prematurity and Birth, Preterm, run by Christiana Care Health Services 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 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 8 Jul 2021. 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?
Decisional regret (time frame: Within the last 14 years). The study lists 2 primary outcomes in all. 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 NCT04074525, 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 8 Jul 2021.