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Pacifier study holds key to better feeding for tiniest babies

NCT ID NCT02696343

Knowledge-focused Sponsor: University of Nebraska Lincoln Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a special pacifier that pulses can help extremely preterm babies learn to feed by mouth. Researchers measured changes in babies' saliva genes and feeding skills. The goal was to find a better way to help these fragile infants feed and grow.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

121 people

The number who actually took part.

Started

Jul 2016

Finished

Mar 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 24 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Extremely preterm infants (EPIs) born between 24 0/7 and 28 6/7 weeks' GA, as determined by obstetric ultrasound at \< 15 weeks or last menstrual period * Enroll EPIs once they have a corrected PCA of ≥ 29 weeks * Approximately equal numbers of males and females, no exclusion based on race/ethnicity Exclusion Criteria: * Chromosomal and congenital anomalies including craniofacial malformation, nervous system anomalies, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia and/or other major gastrointestinal anomalies * Congenital infection * No documented GA * Severe IUGR (3%) * Head circumference \< 10th or \> 90th percentile * Intracranial hemorrhage grades III and IV, seizures * Meningitis * Neurological examination showing abnormal tone or movements of all extremities for PCA * History of necrotizing enterocolitis (stage II and III) * Culture-positive sepsis at the time of study enrollment

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Conditions

The condition(s) this trial relates to.

Feeding Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Feeding behavior Infant, extremely low birth weight

Contacts and locations

Locations

  • CHI St. Elizabeth's Medical Center

    Lincoln, Nebraska, 68512, United States

  • Children's Hospital of Orange County

    Los Angeles, California, 92868-4203, United States

  • Santa Clara Valley Medical Center

    San Jose, California, 95128-2604, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1526, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.