Impact of Serious Pediatric Illness on Parent and Sibling Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

161000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Natural History Study in Pediatric Patients With MYBPC3 Mutation-associated Cardiomyopathy

NCT05112237

Cardiomyopathy

RECRUITING

Understanding Pediatric Chest Pain and Other Symptoms

NCT00166231

Chest Pain

COMPLETED

Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis

NCT00693134

Myocarditis

COMPLETED

Relationship Between EBV and PTLD

NCT00215033

Pediatric Heart Transplant

TERMINATED

Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

NCT03581695

Hypertension, Pulmonary

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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 Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cigna customers as follows:

1. Neonatal Intensive Care Unit (NICU) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams.
2. Critical Congenital Heart Disease (CCHD) cohort: Newborns with critical congenital heart defects who undergo surgery by 12 months of life.
3. Oncology cohort: Patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer.
4. 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.