Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03027440 |
| Other study ID # |
999917036 |
| Secondary ID |
17-CH-N036 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2017 |
| Est. completion date |
July 23, 2024 |
Study information
| Verified date |
April 19, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Suicide rates are rising. In 2013, it was the third leading cause of death in children ages
10-14. It was the second leading cause of death for ages 15-24. Many risk factors for suicide
have been found. But it is hard to predict. Evidence is growing that some factors that may
make people vulnerable to suicide can be identified before birth or in early childhood.
Researchers want to study vulnerability to suicide. They want to look at different kinds of
development. These include prenatal, social, behavioral, cognitive, and neurologic. They will
do this by linking data from the United States Collaborate Perinatal Project (CPP) to the
National Death Index (NDI). The CPP data are from about 50,000 children born to mothers who
enrolled in the 1960s. The CPP observed and examined about 60,000 pregnancies. Then it
followed the babies from when they were born through age 7. The CPP collected data on things
like family and medical history, economic status, and behavior. The NDI has data on the date
and cause of death.
Objective:
To link data from the CPP to the NDI in order to study certain precursors to suicide.
Eligibility:
Offspring born to women who enrolled in the CPP in 1959-1966 and known to be alive at age 7
(Note: at the start of this study around in 2016, the youngest of those still alive would be
50 and the oldest would be 57 years old).
Design:
Data on children from the CPP will be submitted electronically to the NDI. It will be
encrypted and data from the NDI will be deidentified to protect confidentiality. It will then
be merged with existing CPP data. Researchers will analyze the data.
...
Description:
Objective:
The overarching objective of this study is to ascertain the vital status and cause-specific
mortality of children born to participants in the Collaborative Perinatal Project (CPP)
between 1959 and 1966 in order to investigate domains of vulnerability to suicide that are
hypothesized to be established in early childhood. This will be accomplished by linking
existing data in the NICHD-CPP cohort to the National Death Index (NCHS National Center for
Health Statistics). This project does not involve direct contact with human subjects
participants.
The rationale for this project is as follows. Suicide rates are rising, from 10.43/100,000 in
2000 to 13.02/100,000 in 2013. In 2013, suicide was the third leading cause of death among
children ages 10-14 years and the second leading cause of death between ages 15 and 24.
Suicide accounts for 800,000 years of potential life lost annually. In addition to an
economic impact exceeding $40 billion per year, it has devastating personal impacts on
survivors as well as the general public. Although numerous risk factors have been identified,
including prior attempts, traumatic or stressful life events, and sociodemographic,
psychiatric, psychological, biological and family, and socioeconomic characteristics,
accurate prediction of suicide remains elusive even in high-risk groups.
To date, epidemiologic studies of suicide have largely focused on proximal risk factors and
developmental stages beyond the initial formation of vulnerability, despite growing evidence
that frames psychiatric disorders as neurodevelopmental disorders. Evidence is also
increasing that adolescent and adult precipitants of suicide have roots in early childhood.
Study population:
The study population consists of 52,966 offspring born to women who enrolled in the CPP and
known to be alive at age 7 years; at the time of the NDI search, in 2016, the youngest of
those still alive would be 50 and the oldest would be 57 years old. The CPP involved the
systematic and extensive observation and examination of 58,760 pregnancies, including
collection of blood samples collected at the first and subsequent prenatal visits, and
follow-up assessments of offspring through the first 7 years of life (Niswander and Gordon,
1972). National follow-up rates for surviving offspring (96.7% of study births at age 7
years) were 88% at year 1, 75% at year 4, and 79% at year 7.
Design:
This study consists of secondary analyses in which CPP offspring data will be linked to the
National Death Index to determine vital status and cause(s) of death. NICHD is the steward of
personally identifying information from the CPP. Data on offspring, including date (month,
day, and year), name, father s surname, state of birth, and race/ethnicity will be submitted
to the National Death Index (NDI) for a record search covering the years 1979 to 2016 (all
years included within the NDI). Results of the NDI linkage will be anonymized and then merged
with existing CPP data for statistical analyses. Hypotheses to be tested include the
following:
Examples of hypotheses to be tested include the following:
1. Being born small for gestational age (SGA), low birth weight (LBW), and exposure to
maternal metabolic (e.g., gestational diabetes) and psychiatric conditions will be
associated with an increased risk for suicide mortality.
2. Family socioeconomic disadvantage, residential instability, and family disruption during
the first 7 years of life will be associated with an increased risk of suicide
mortality.
3. Children whose behavioral profiles are characterized by low attention, conduct problems,
and emotional withdrawal will have an elevated risk of suicide.
4. Children with lower scores on tests of intelligence at ages 4 and 7 will have an
increased risk of suicide.
5. Neurological soft signs and neurological hard signs detected in clinical examinations
during early childhood will be associated with later suicide risk.
6. There will be a systematic pattern of differences between 275 suicide cases and 550
matched controls selected from among the remaining CPP offspring, with cases exhibiting
a pattern of biomarker concentrations consistent with a perturbation of the maternal
immune system from what would be expected during a normal pregnancy.
Outcome measures:
Suicide mortality.
