Offspring Neurodevelopment and Growth After Early Antihypertensive Therapy or Preeclampsia in Women with Chronic Hypertension and Pregnancy (CHAP Child)

DH

David Haas, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 100 Years Gender: All Genders Phase: N/A 2 Locations

Brief Description

What is the purpose of this study?
This study is being conducted to evaluate the current state of knowledge regarding long-term child outcomes among children born to women with mild CHTN who received antihypertensive therapy in pregnancy or who had preeclampsia. This study will compare long-term outcomes, including neurodevelopment and growth. At the age of 7 years or greater, a 2.5 hour in-person child visit will allow for measurement of ND, growth and other outcomes (BMI, body circumferences and BP). Biospecimens will be stored for future studies as well.  The CHAP Child Follow-up study will be conducted at primary CHAP RCT participating sites (up to 60 across 31 US states).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is only enrolling children of mothers who enrolled in CHAP (delivered 2015-2021)

Detailed Description

What will happen during the study?
  • Study participation will consist of one in-person visit at the age of 7 years or greater, which includes the collection of medical history, collection of urine and saliva, and completion of questionnaires. (this visit is expected to last approximately 2.5 hours).
  • We will also contact participants yearly to collect growth records (height and weight) until they reach the age of 7 years.
  • Participants may also be contacted for future research.

Eligibility of study

Inclusion Criteria:

  • Children of mothers enrolled in CHAP (delivered 2015-2021) who agree to participate in the follow-up study.

Exclusion Criteria for follow-up study:

  • Children of mothers enrolled in CHAP (delivered 2015-2021) who declined to have their child participate in the follow-up study, including mothers who declined to be contacted regarding future research studies.
  • Children who refuse to assent to the follow-up study.
  • Children and/or parents who are unable to communicate with study staff due to a language barrier.
  • Children and/or parents who are deemed lost to follow-up (LTFU).

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.