N/A N=152 Randomized Single-blind Prevention

Opaque Bottle Study

Opaque Bottles · Conventional, Clear Bottles

Bottom Line

View on ClinicalTrials.gov: NCT03711370 ↗

Enrolled (actual)

152

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Infant Intake (mL) During the Observed Feeding — 116.7; 119.5; 107.5; 114.9 mL — p=0.76

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clear Bottle (Other); Opaque Bottle (Other)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: California Polytechnic State University-San Luis Obispo
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Infant Intake (mL) During the Observed Feeding	116.7; 119.5; 107.5; 114.9	0.76
PRIMARY Maternal Sensitivity to Infant Cues	12.3; 12.6; 12.2; 12.2	0.64
PRIMARY Infant Weight-for-length Z-scores	0.22; 0.69	0.02 sig
SECONDARY Change in Infant Waist Circumference	44.7; 43.1	0.07
SECONDARY Change in Infant Triceps Skinfolds z-Scores	-0.52; -0.77	0.70
SECONDARY Change in Infant Subscapular Skinfolds z-Scores	0.67; 0.37	—
SECONDARY Mothers' Perceptions of the Bottles	24; 24; 6; 6	—

Summary

The proposed research aimed to conduct an intervention study assessing the effect of feeding mode (clear versus opaque bottle) on the quality and outcome of infant feeding interactions.

Eligibility Criteria

Inclusion Criteria

mothers 18-40-years of age
infants 50% of feedings)
mother predominantly or solely responsible for infant feeding
dyad has a pediatrician and plans to attend infant well-visits
mother is willing to use stainless-steel bottles and to provide the study with her current bottles, which would be returned after study completion
prior to the introduction of solid foods.

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)
currently using opaque bottles

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03711370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.