Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

Plain-language summary

This study examines the effect of a pacifier device called the NTrainer on oral feeding and salivary gene expression in premature (preterm) infants. Extremely preterm babies born between 24 and 28 weeks of gestation could take part. It was carried out as a trial without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Nebraska Lincoln

Intervention

NTrainer, SHAM blind pacifier

Start date

7/13/2016

Estimated completion

3/31/2023

Countries

United States

Related genes

Locations

• Los Angeles, United States
• San Jose, United States
• Boston, United States
• Lincoln, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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