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PI Name Protocol Number Protocol Title Status Approval Date
KARPEN, HEIDI E.
H-17422 FEEDING AND CARE PRACTICES IN NEONATES AND INFANTS WITH SHORT BOWEL SYNDROME Approved 4/19/2006

 

Funding Source

Baylor

Background Info

Intestinal failure is characterized by the inadequate digestion and/or absorption of nutrients leading to malnutrition and/or dehydration. The most common cause of intestinal failure in the neonate is short bowel syndrome (SBS), which occurs mainly as a consequence of massive small bowel resection. Although SBS may be congenital or acquired, such as in congenital intestinal anomalies or necreotizing enterocolitis (NEC), in neonates it often represents a combination of the two entities.

The management of neonates and infants with SBS is clinically challenging. They need close monitoring to ensure proper growth and nutrition, as well as to recognize and treat associated complications. Although survival of these patients has improved with the advent of parenteral nutrition, there is also significant morbidity associated with this form of nutrition, including prolonged hospitalization, sepsis from central line infections and cholestatic liver disease. Thus, an important goal is to promote optimal intestinal adaptation as early as possible in order to transition patients to full enteral feedings, if possible. Current data on the optimal management and treatment options for this group of neonates and infants is sorely lacking.

Moreover, many of these patients have co-morbid conditions and prolonged hospitalizations which increase the complexity of their care (e.g. chronic lung disease, neurologic impairment). Establishment of a designated multidisciplinary team and evidence based protocols for treatment of these infants would significantly benefit this complicated, fragile patient population.

Purpose and Objectives

The purpose of this protocol is to collect prospective and retrospective data on patients who meet the criteria for short bowel syndrome (SBS) over a period of 1-2 years.

Our primary objectives are to

  1. document current feeding and care practices, complications and outcomes for babies with SBS at the consolidated Baylor Neonatology sites (i.e. Texas Children's Hospital and Ben Taub Newborn Centers- Level II and Level III nurseries)
  2. formulate a cohesive care plan for babies with SBS based using an evidenced based approach and
  3. plan for future prospective, randomized control trials of formulas, feeding strategies and potential disease modifying agents.
Design

Chart/scan/record review

Potential Risks

None- all of the information collected is from tests and studies that were performed in the routine care of these babies while they were admitted to the Baylor Consolidated NICUs. There is a minor risk of breech of confidentiality, but steps have been implemented to maintain intregrity of the records.

Potential Benefits

No real benefit will be gained by these individual patients from whom we collect data as proposed.

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