Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 1:04 AM
Study NCT ID:
NCT00579605
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing to Promote Sustained Breastfeeding
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)
Status:
COMPLETED
Status Verified Date:
2023-08
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:
1. Evaluate the cultural appropriateness of an intervention protocol related to: a) motivational interviewing technique; b) stool, urine, and breast milk sample collection; and c) infant breastfeeding test weight procedure.
2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4) and evaluate fecal and breast milk samples of infants for human milk oligosaccharide levels.
2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4) and evaluate fecal and breast milk samples of infants for human milk oligosaccharide levels.
Detailed Description:
The incidence of asthma, the most common serious chronic inflammatory disease among children, is rising each year. Therefore nursing interventions aimed at promoting infant immunity and mitigating factors to which the infant may be exposed may reduce the complications of this chronic illness. Breastfeeding is an ideal initial prevention strategy that strengthens the infant's immune system. In addition, the identification of biomarkers that reflect infant immune response sets the stage for the evaluation of nursing interventions targeted to decrease the impact of this chronic inflammatory disease. Although more mothers currently initiate breastfeeding, they do not sustain breastfeeding for the recommended 6 to 12 months. In general, Native American mothers' breastfeed for a shorter period of time and mothers in rural setting have fewer resources to support breastfeeding.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UNMC MIHERO Internal Grant | OTHER_GRANT | University of Nebraska Medical Center | View |