Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Prematurity Clinical Trial

Official title:

Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062815
• Other study ID #: 20080651
• Status: Terminated
• Phase: N/A
• First received: February 3, 2010
• Last updated: November 20, 2015
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: November 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Hypothesis to be Tested:

Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure.

There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) < 32 weeks and birth weight <1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC).

We therefore hypothesize that infants with gestational age (GA) <32 weeks and birth weight (BW) between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

1. Infants expected to need prolonged PN (receiving >75% PN on dol 7) with the following risk factors:

1. Prematurity with gestational age (GA) <32 weeks AND birth weight <1500g. OR

2. Congenital anomaly of the gastrointestinal tract regardless of GA or BW

2. Screening direct bilirubin prior to the initiation of parenteral nutrition <2mg/dL.

Exclusion Criteria:

1. Infants with major congenital anomalies, other than those of the gastrointestinal tract.

2. Infants with known obstruction of the hepatobiliary tract.

3. Infants with suspected congenital infection or suspected genetic/metabolic syndrome predisposing them to cholestasis based on direct bilirubin > 2mg/dL prior to instituting PN.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholestasis
• Enterocolitis
• Enterocolitis, Necrotizing
• Gastroschisis
• Intestinal Atresia
• Necrotizing Enterocolitis
• Prematurity

Intervention

Dietary Supplement:
• Parenteral Nutrition
Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.

Locations

Country	Name	City	State
United States	Holtz's Children's Hospital- University of Miami/Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is a decreased peak direct bilirubin in infants with GA <32 weeks and BW between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, requiring prolonged PN (receiving >75% PN on dol 7).		Peak direct bilirubin during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days)	No
Secondary	A secondary outcome is to determine if the incidence of PN- Associated Cholestasis is lower in infants receiving cyclic PN over 20 hours compared to infants receiving standard continuous PN over 24 hours.		Incidence of cholestasis (direct bilirubin >2mg/dL) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days)	No
Secondary	A secondary outcome in infants who develop PN-Associated Cholestasis is to evaluate if those receiving cyclic PN will have a shorter duration of cholestasis compared to infants receiving continuous PN.		Duration of cholestasis (# of days direct bilirubin > 2mg/dL) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days) .	No
Secondary	A secondary outcome is to evaluate if infants receiving cyclic PN will have equivalent rates of growth compared to infants receiving continuous PN.		Rate of growth (g of weight and cm of length and head circumference gained per week) during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days).	No