Please select the eligibility criteria that correspond to the clinical trial below.
Title: Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Brief Summary: Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation between gene expression, oral somatosensory stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age (CA) on 180 extremely preterm infants \[EPIs\] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA) enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral feeding skills, along with objective salivary gene expression data to monitor response to treatment and feeding development, will result in a novel, objective, and personalized approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.


Options:
A: Inclusion Criteria:

* healthy term infants birth weight \>2.50kg, gestational age \>37 weeks

Exclusion Criteria:

-
B: 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
C: Inclusion Criteria

- Birth Gestational age 26 0/6 - 30 6/7 weeks

Exclusion Criteria

* Chromosomal abnormalities
* Congenital anomalies included but not limited to
* craniofacial malformation
* cyanotic congenital heart disease
* gastroschisis
* omphalocele
* diaphragmatic hernia or other major gastrointestinal anomalies
* Major neurological anomaly
* Infants with history of surgical necrotizing enterocolitis (stage III)
* Infants with vocal cord paralysis
* Infants with neonatal seizures
* Infants with meningitis at time of enrollment
* Infants who are nippling all feeds at the time of enrollment
* Infants with narcotic abstinence syndrome (NAS)
* Infants enrolled in another clinical study
D: Inclusion Criteria:

* Term babies born to mothers by normal vaginal delivery in the study period.

Exclusion Criteria:

1. Babies with major congenital malformation.
2. Multiple pregnancy
3. Babies requiring resuscitation beyond the initial steps
4. Babies requiring care in the neonatal intensive care unit.
5. Maternal problems requiring immediate care

   * Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
   * Imminent eclampsia
   * Severe bleeding
   * Mother with significant surgical or medical illness requiring separation of the baby from the mother.
6. Small for dates and large for dates babies
7. Infants of diabetic mother
8. Maternal refusal of consent.

Answer: B