Family Members of: Newborns Extremely PrematureNCT03971344
Impact of Serious Pediatric Illness on Parent and Sibling Health
An observational study of Family Members of: Newborns Extremely Premature and Family Members of: New Pediatric Oncology Patients, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Members of: Newborns Extremely Premature, Family Members of: New Pediatric Oncology Patients, Family Members of: Critical Congenital Heart Defect Patients
- How many people
- 161,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 31 Jul 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: See Eligibility Criteria
Who may be able to join
- Cigna customers as follows:
- Neonatal Intensive Care Unit (NICU) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams.
- Critical Congenital Heart Disease (CCHD) cohort: Newborns with critical congenital heart defects who undergo surgery by 12 months of life.
- Oncology cohort: Patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer.
- Severe Neurological Impairment (NI) cohort: Patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans.
- For each index patient in a particular SPI cohort, Investigators randomly identified up to four children of the same ages as the index patient but who do not have the specific SPI. The matching by age was as follows: in months if < 3 years; and in years if age > or = 3 years. Cigna then identified all family members, using both definitions of "family members" described above.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family.
Read the detailed description
Although standard pediatric practice, when caring for a child with serious illness, is to provide support to the child's parents and any siblings, little quantitative information exists regarding what could be considered the "collateral impact" on other family members of having a child with serious illness in the family. This study seeks to provide such information, using existing claims data from the health insurance company, Cigna, to identify children with serious illness and then examining the health and health care of their family members. The investigators hypothesize that, compared to control families without a sick child, parents and siblings of children with serious pediatric illness (SPI) will have more new mental and physical health diagnoses, more new prescriptions, increased levels of Emergency Department (ED) and acute care services, and reduced levels of use of recommended chronic disease management for pre-existing conditions and of preventative services.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Family members of newborns extremely premature | Parents and siblings (if any) of infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams. | |
| Family members of new pediatric oncology patients | Parents and siblings (if any) of patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer. | |
| Family members of critical congenital heart defect patients | Parents and siblings (if any) of newborns with critical congenital heart defects who typically undergo surgery by 12 months of life. | |
| Family members of children with severe neurological impairment | Parents and siblings (if any) of patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New mental health diagnoses among parents
Outcome will be assessed based on diagnoses in de-identified claims data
Measured: 3 years
New mental health diagnoses among siblings
Outcome will be assessed based on diagnoses in de-identified claims data
Measured: 3 years
New physical health diagnoses among parents
Outcome will be assessed based on diagnoses in de-identified claims data
Measured: 3 years
New physical health diagnoses among siblings
Outcome will be assessed based on diagnoses in de-identified claims data
Measured: 3 years
New mental health prescriptions among parents
Outcome will be assessed based on prescription data in de-identified claims data
Measured: 3 years
New mental health prescriptions among siblings
Outcome will be assessed based on prescription data in de-identified claims data
Measured: 3 years
New physical health prescriptions among parents
Outcome will be assessed based on prescription data in de-identified claims data
Measured: 3 years
New physical health prescriptions among siblings
Outcome will be assessed based on prescription data in de-identified claims data
Measured: 3 years
Secondary outcomes (8)
Emergency department usage among parents
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Emergency department usage among siblings
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Ambulatory care usage among parents
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Ambulatory care usage among siblings
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Hospitalizations among parents
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Hospitalizations among siblings
Outcome will be assessed based on encounter data in de-identified claims data
Measured: 3 years
Adherence to chronic disease management standards among parents
Outcome will be assessed based on data in de-identified claims data
Measured: 3 years
Receipt of well-child visit and childhood immunizations among siblings
Outcome will be assessed based on data in de-identified claims data
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start30 Jan 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Members of: Newborns Extremely PrematureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Retrospective
- Enrolment
- 161,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Cigna Foundation
- Responsible party
- Sponsor
- Investigators
- Chris Feudtner, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971344
- Sponsor's protocol ID
- FP00024612
- Status last verified
- Aug 2020
- First submitted
- 30 May 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serious Pediatric Illness on Parent and Sibling Health
- ClinicalTrials.gov ID
- NCT03971344
- Acronym / sponsor ID
- FP00024612
- Conditions
- Family Members of: Newborns Extremely Premature, Family Members of: New Pediatric Oncology Patients, Family Members of: Critical Congenital Heart Defect Patients, Family Members of: Children Severe Neurological Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161,000 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Cigna Foundation
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 3 Jun 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.
To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family.
Detailed description
Although standard pediatric practice, when caring for a child with serious illness, is to provide support to the child's parents and any siblings, little quantitative information exists regarding what could be considered the "collateral impact" on other family members of having a child with serious illness in the family. This study seeks to provide such information, using existing claims data from the health insurance company, Cigna, to identify children with serious illness and then examining the health and health care of their family members. The investigators hypothesize that, compared to control families without a sick child, parents and siblings of children with serious pediatric illness (SPI) will have more new mental and physical health diagnoses, more new prescriptions, increased levels of Emergency Department (ED) and acute care services, and reduced levels of use of recommended chronic disease management for pre-existing conditions and of preventative services.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Family members of newborns extremely premature | – | –Parents and siblings (if any) of infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams. |
| Family members of new pediatric oncology patients | – | –Parents and siblings (if any) of patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer. |
| Family members of critical congenital heart defect patients | – | –Parents and siblings (if any) of newborns with critical congenital heart defects who typically undergo surgery by 12 months of life. |
| Family members of children with severe neurological impairment | – | –Parents and siblings (if any) of patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- See Eligibility Criteria
Key inclusion criteria (6 listed)
- Cigna customers as follows:
- For each index patient in a particular SPI cohort, Investigators randomly identified up to four children of the same ages as the index patient but who do not have the specific SPI. The matching by age was as follows: in months if < 3 years; and in years if age > or = 3 years. Cigna then identified all family members, using both definitions of "family members" described above.
Key exclusion criteria (1 listed)
- -
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
New mental health diagnoses among parents
Time frame: 3 years
Outcome will be assessed based on diagnoses in de-identified claims data
New mental health diagnoses among siblings
Time frame: 3 years
Outcome will be assessed based on diagnoses in de-identified claims data
New physical health diagnoses among parents
Time frame: 3 years
Outcome will be assessed based on diagnoses in de-identified claims data
New physical health diagnoses among siblings
Time frame: 3 years
Outcome will be assessed based on diagnoses in de-identified claims data
New mental health prescriptions among parents
Time frame: 3 years
Outcome will be assessed based on prescription data in de-identified claims data
New mental health prescriptions among siblings
Time frame: 3 years
Outcome will be assessed based on prescription data in de-identified claims data
New physical health prescriptions among parents
Time frame: 3 years
Outcome will be assessed based on prescription data in de-identified claims data
New physical health prescriptions among siblings
Time frame: 3 years
Outcome will be assessed based on prescription data in de-identified claims data
8 secondary outcomes
Emergency department usage among parents
Time frame: 3 years
Emergency department usage among siblings
Time frame: 3 years
Ambulatory care usage among parents
Time frame: 3 years
Ambulatory care usage among siblings
Time frame: 3 years
Hospitalizations among parents
Time frame: 3 years
Hospitalizations among siblings
Time frame: 3 years
Adherence to chronic disease management standards among parents
Time frame: 3 years
Receipt of well-child visit and childhood immunizations among siblings
Time frame: 3 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 31 Aug 2020.
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.
Chris Feudtner, MD principal investigator
Children's Hospital of Philadelphia
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 Family Members of: Newborns Extremely Premature and Family Members of: New Pediatric Oncology Patients, run by Children's Hospital of Philadelphia 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 6 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 31 Aug 2020. 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?
New mental health diagnoses among parents (time frame: 3 years). The study lists 8 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 31 Aug 2020.