Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT07101757
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Neurodevelopmental Outcomes
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby.
The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.
The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.
Detailed Description:
The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child.
There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.
Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.
The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.
There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.
Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.
The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: