Bottle Feeding, Breastfeeding
Conditions
Keywords
infant feeding, feeding interactions, maternal feeding practices, breastfeeding, bottle-feeding
Brief summary
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.
Interventions
BEHAVIORALMode of Feeding (breastfeeding versus bottle-feeding)
Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
California Polytechnic State University-San Luis Obispo
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Mothers 18-40 years of age * Infants 0-24 weeks of age * Infants who have not yet been introduced to complementary foods and beverages * Dyads are breast- and bottle-feeding * Mother is predominantly or solely responsible for infant feeding
Exclusion criteria
* preterm birth (i.e., gestational age \<37 weeks) * low birth weight (\<2500 g) * maternal smoking during pregnancy * current or past medical conditions that interfere with oral feeding * history of slow growth or failure to thrive * weight for length percentile \<5th * diagnosed developmental delay (e.g., Down's syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Intake During the Observed Feeding (mL) | 2-hour period | 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. |
| Maternal Sensitivity to Infant Cues | 2-hour period | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 94 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 86 Participants |
| Region of Enrollment United States | 94 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 | 0 / 47 | 0 / 47 |
Outcome results
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.
Time frame: 2-hour period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast- Versus Bottle-feeding | Infant Intake During the Observed Feeding (mL) | Breastfeeding Condition | 91.9 mL | Standard Error 5 |
| Breast- Versus Bottle-feeding | Infant Intake During the Observed Feeding (mL) | Bottle-feeding Condition | 87.6 mL | Standard Error 5.2 |
p-value: 0.634Mixed Models Analysis
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.
Time frame: 2-hour period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast- Versus Bottle-feeding | Maternal Sensitivity to Infant Cues | Breastfeeding Condition | 14.7 units on a scale | Standard Error 0.2 |
| Breast- Versus Bottle-feeding | Maternal Sensitivity to Infant Cues | Bottle-feeding Condition | 14.3 units on a scale | Standard Error 0.2 |
p-value: 0.115Mixed Models Analysis