Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)

Completed

Conditions studied: Preterm Birth

In brief

The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and breathing pattern. In preterm infants less than 32 weeks gestation, this ability is not usually effective enough to sustain full oral feeds. In the interim, infants are fed by gavage tube until they are mature enough to take milk directly from the breast or bottle (Pinelli, Symington, 2005). Non-nutritive sucking has been used during gavage feeding and in the transition from gavage to breast/bottle feeding. The rationale for this intervention is that non-nutritive sucking facilitates the development of sucking behavior and improves digestion of enteral feeds.

Key facts

Study ID

NCT01069744

Run by

KC BioMediX, Inc

People needed

71

Starts

2007-11-01

Expected to finish

2008-11-01

Last updated by the study team

2010-02-17

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Estational age between 23 weeks and 0/7 days and 34 weeks as per the best estimate by the neonatologist.
• No major anomalies (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
• Ready for oral feedings. Neonates who meet eligibility criteria (A-E) will be assessed by the health care team (neonatology and occupational therapist) with the NTrainer beginning at 32 weeks post menstrual age A. Hemodynamically stable and off all vasopressors B. Tolerating 120 ml/kg/day of enteral feedings C. Respiratory rate <80 breaths per minute D. Alert and active neurologic exam appropriate for post-menstrual age E. No signs of sepsis or intolerance of gastric feedings

You may not qualify if…

• Gestational age < 23 weeks or > 34 weeks
• Any major congenital anomalies
• Not ready for oral feedings

Where it is running

• Overland Park Regional Medical Center — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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