An interventional study of Typical Nipple and Challenging Nipple in Obesity; Familial, Pregnancy Related and Infant Behavior, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 10 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this study...
Mother
-Current or previous participation in the PLAN study resulting in a live birth.
Child
First the typical nipple and then challenging nipple
Behavioral: Typical Nipple · Behavioral: Challenging Nipple
First the challenging nipple and then the typical nipple
Behavioral: Typical Nipple · Behavioral: Challenging Nipple
Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.
Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).
Suck effect
Sucking will be measured with the NFANT® Feeding Solution
Time frame: Up to 6 weeks
Sucking pressure
Sucking will be measured with the NFANT® Feeding Solution
Time frame: Up to 6 weeks
Sucking frequency
Sucking will be measured with the NFANT® Feeding Solution
Time frame: Up to 6 weeks
Milk/Formula intake
Time frame: Up to 6 weeks
Milk/Formula consumption rate
Time frame: Up to 6 weeks
Number of Feedings Over 24 Hours
Time frame: Up to 6 weeks
Total Hours of Sleep per 24 Hours within 24 hours of intervention
Time frame: Up to 6 weeks
Total Night Wake-ups within 24 hours of intervention
Time frame: Up to 6 weeks
Plan to share: No — The researchers may consider sharing data but hesitate due to difficulties de-identifying data of small samples. Please contact the study team if you have questions.
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Jul 2025, 4 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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