Probiotics/TPN in the NICU

Pediatrix

Status: Completed

Conditions: Total Parenteral Nutrition; Necrotizing Enterocolitis of Newborn

Treatments: Dietary Supplement: Similac Probiotic Tri-Blend

Study type: Observational

Funder types: Other

Identifiers

NCT04977817

822180615

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants < 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Birth weight < 1500 grams or GA < 32 weeks

Exclusion criteria

• Life threatening congenital anomalies
• Transfers to another facility prior to discharge home
• Investigator discretion to exclude if deemed necessary

Trial design

150 participants in 2 patient groups

Control Group

Description:

By using the Baby Steps Program, neonates less than or equal to 1500 grams and less than 32 weeks GA will be identified. The control group will contain those that did not receive probiotics.

Treatment Group

Description:

By using the Baby Steps Program, neonates less than or equal to 1500 grams and less than 32 weeks GA will be identified. The treatment group will contain those neonates that did receive the probiotic nutritional supplement.

Treatment:

Dietary Supplement: Similac Probiotic Tri-Blend