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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD096164 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding First, then Bottle-feeding | Mother-infant dyads were observed while breastfeeding during their first visit to our laboratory and were observed while bottle-feeding expressed breast milk during their second visit to our laboratory. |
| |
| Bottle-feeding First, then Breastfeeding | Mother-infant dyads were observed while bottle-feeding expressed breast milk during their first visit to our laboratory and were observed while breastfeeding during their second visit to our laboratory. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mode of Feeding (breastfeeding versus bottle-feeding) | Behavioral | Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant Intake During the Observed Feeding (mL) | For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle. | 2-hour period |
| Maternal Sensitivity to Infant Cues | Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues. | 2-hour period |
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Inclusion Criteria:
Exclusion Criteria:
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A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.
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| Name | Affiliation | Role |
|---|---|---|
| Alison K Ventura, PhD | Cal Poly | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion | San Luis Obispo | California | 93401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33939269 | Result | Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3. |
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We do not currently plan to make individual participant data available to other researchers.
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There were no significant events in the study (for example, wash out, run-in) that occurred after participant enrollment, but prior to the first within-subject condition.
Mothers of infants under 6 months of age were recruited through advertisements on social media platforms (e.g. Facebook and Instagram); advertisements in local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics; announcements in birthing, breastfeeding and parenting classes; and flyers displayed at local businesses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breastfeeding First, Then Bottle-feeding | Mother-infant dyads in this group breastfed during the first visit, then bottle-fed expressed breast milk during the second visit. |
| FG001 | Bottle-Feeding First, Then Breastfeeding | Mother-infant dyads in this group bottle-fed expressed breast milk during the first visit, then breast-fed during the second visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis population included mothers (n = 47) and their healthy infants <6 months of age (n = 47).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This was a within-subject study; all mother-infant dyads (47 mothers + 47 infants = 94 participants total) were exposed to both conditions and the order of presentation was counterbalanced across dyads. Because all dyads were randomized to receive all interventions, all will be combined into one arm/group for the summary that follows. Mode of Feeding (breastfeeding versus bottle-feeding): Infants will be breastfed during one lab visit and bottle-fed (with expressed breast milk) during the other. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mother Age at Study Entry | Data are for mothers only (n = 47) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Intake During the Observed Feeding (mL) | For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle. | Posted | Mean | Standard Error | mL | 2-hour period | dyads | dyads |
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For the duration of each participant's participation in the study: ~1 week
Definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breastfeeding Condition - Mothers | Mother-infant dyads were observed while breastfeeding during one visit to our laboratory and bottle-feeding expressed breast milk during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately. |
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This study consisted of mothers who were exclusively or predominantly breastfeeding and who fed expressed breast milk (not formula) when bottle-feeding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Ventura | California Polytechnic State University | (805) 756-5693 | akventur@calpoly.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 5, 2018 | Oct 10, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Mean |
| Standard Deviation |
| years |
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| Age, Continuous | Infant Age at Study Entry | Data are for infants only (n = 47) | Mean | Standard Deviation | months |
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| Sex: Female, Male | Data are for mothers only (n = 47) | Count of Participants | Participants |
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| Sex: Female, Male | Data are for infants only (n = 47) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | All data collection took place in San Luis Obispo and Santa Barbara Counties, California | Number | participants |
|
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| dyads |
|
|
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| Primary | Maternal Sensitivity to Infant Cues | Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues. | Posted | Mean | Standard Error | units on a scale | 2-hour period | dyads | dyads |
|
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Breastfeeding Condition - Infants | Mother-infant dyads were observed while breastfeeding during one visit to our laboratory and bottle-feeding expressed breast milk during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG002 | Bottle-feeding Condition - Mothers | Mother-infant dyads were observed while bottle-feeding expressed breast milk during one visit to our laboratory and breastfeeding during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG003 | Bottle-feeding Condition - Infants | Mother-infant dyads were observed while bottle-feeding expressed breast milk during one visit to our laboratory and breastfeeding during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately. | 0 | 47 | 0 | 47 | 0 | 47 |
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