Increasing Mothers' Own Milk Feeding in the Neonatal ICU
NCT07932652, Not applicable, Recruiting, The University of Texas Health Science Center, Houston
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Increasing Mothers' Own Milk Feeding in the Neonatal ICU | ClinicalTrials.gov |
| NCT number | NCT07932652 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,176 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The University of Texas Health Science Center, Houston | ClinicalTrials.gov |
| Conditions | Mothers' Own Milk Feeding, Cessation or Non-initiation of Mothers' Own Milk Feeding | ClinicalTrials.gov |
| Interventions | Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT), Usual Lactation Support | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of infants who receive mothers' own (breast)milk (MOM) feeding within 24 hours of infant neonatal intensive care unit (NICU) discharge | Within 24 hours of infant hospital discharge from the NICU | ClinicalTrials.gov | |
| Secondary | Number of infants' mothers who initiate mothers' own (breast)milk (MOM) feeding | From the time of infant date of birth to 6 months chronological age of infant (about 6 months) | ClinicalTrials.gov | |
| Secondary | Total number of days from infant mothers' own (breast)milk (MOM) feeding initiation to cessation | From the time of infant date of birth to 6 months chronological age of infant (about 6 months) | ClinicalTrials.gov | |
| Secondary | Proportion of days that infants receive mothers' own (breast)milk (MOM) during neonatal intensive care unit hospitalization | From the time of infant admission to NICU to time of infant hospital discharge from NICU (1-180 days) | ClinicalTrials.gov | |
| Secondary | Feasibility of intervention training as indicated by number of training sessions attended by nurses specializing in lactation support as assessed by sign-in attendance logs | From start to finish of training (3 non-consecutive days) | ClinicalTrials.gov | |
| Secondary | Acceptability of Lactation Specialist (LS) intervention training and MIACT as assessed by completion of self-report evaluations completed by lactation specialists | After initial MIACT training and at study closeout | Self-reported ratings of LS intervention training and MIACT will be completed by nurses specializing in lactation support (i.e., lactation specialists) to assess intervention acceptability. Total score ranges from 1 (highly unacceptable) to 7 (highly acceptable). | ClinicalTrials.gov |
| Secondary | Acceptability of LS intervention as assessed by completion of self-report evaluations completed by mothers | At time of infant hospital discharge from NICU (1-180 days after admission to NICU) | Self-reported ratings of LS intervention will be completed by mothers to assess intervention acceptability. Total score ranges from 1 (strongly disagree) to 7 (strongly agree). | ClinicalTrials.gov |
| Secondary | Intervention implementation adherence as indicated by percentage of MIACT components delivered as assessed by MIACT intervention checklists completed by lactation specialists | During the time of MIACT intervention implementation (about 9 months) | ClinicalTrials.gov | |
| Secondary | Total number of days infant is in the NICU | From the time of infant admission to NICU to time of infant hospital discharge form NICU (1-180 days after admission to NICU) | ClinicalTrials.gov | |
| Secondary | Number of lactation referrals | From the time of infant admission to NICU to time of infant hospital discharge form NICU (1-180 days after admission to NICU) | ClinicalTrials.gov | |
| Secondary | Mother-to-infant bonding as assessed by the Mother-to-Infant Bonding Scale | Baseline and at infant hospital discharge from the NICU (1-180 days after admission to NICU)). | Total score ranges from 0 to 24, with higher scores indicating greater levels of bonding difficulties or weaker emotional ties. | ClinicalTrials.gov |
| Secondary | Maternal depressive symptoms as assessed by score on the Center for Epidemiological Studies Depression Scale | Baseline, at infant hospital discharge from the neonatal intensive care unit (NICU), and when infants reach 6 months of chronological age | Total score ranges from 0 to 60, with a higher score indicating greater frequency and severity of depressive symptoms | ClinicalTrials.gov |
| Secondary | NICU stress as assessed by the Parental Stressor Scale (Neonatal Intensive Care Unit) | Baseline or at infant hospital discharge from the NICU (1-180 days after admission to NICU). | Total subscales and overall scores range from item averages of 1 (not at all stressful) to 5 (extremely stressful). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)