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Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions

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ClinicalTrials.gov Identifier: NCT02633384
Recruitment Status : Terminated (One of the intravenous lipid emulsions was retired from the market)
First Posted : December 17, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Luís Pereira-da-Silva, Centro Hospitalar de Lisboa Central

Brief Summary:

Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to receive enteral nutrition for a long period of time, during which they require exclusive PN. In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions (ILE) used in PN may promote PNAC or protect against it depending on their composition. Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation emulsions, the α-tocopherol content is higher than the gamma-tocopherol content, acting as an antioxidant, preventing lipid peroxidation.

The incidence and severity of PNAC in term and near-term infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective from PNAC than Lipofundin®.

Single-center, randomized, controlled and double-blinded trial on consecutive neonates admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective surgery of congenital anomaly of the digestive tract or indirectly affecting the digestive tract. Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum intervention: exclusive PN for at least 1 week.

Main outcome: incidence of cholestasis (conjugated serum bilirubin >1 mg/dl [34 mmol/L]). Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into account the correlation structure between measures in time. Crude and adjusted odds-ratios with corresponding 95% confidence intervals are calculated.


Condition or disease Intervention/treatment Phase
Intrahepatic, Cholestasis Other: SMOFlipid Other: Lipofundin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incidence and Severity of Parenteral Nutrition Associated Cholestasis in Neonates Subjected to Major Surgery, Using Two Mixed Intravenous Lipid Emulsions
Study Start Date : August 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMOFlipid
infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a new generation intravenous lipid emulsion
Other: SMOFlipid
Exclusive total parenteral nutrition using a new generation intravenous lipid emulsion composed of 30% LCT n-6 (soybean oil), 30% MCT (coconut oil), 25% monounsaturated fatty acids (olive oil), 15% LCT n-3 (fish oil) and α-tocopherol
Other Name: SMOFlipid® (Fresenius Kabi)

Lipofundin
infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a current intravenous lipid emulsion
Other: Lipofundin
Exclusive total parenteral nutrition using a current intravenous lipid emulsion composed of 50% LCT (soybean oil) and 50% MCT (coconut oil)
Other Name: Lipofundin® (B Braun)




Primary Outcome Measures :
  1. Incidence of cholestasis [ Time Frame: From recruitment to full enteral feeding per mouth (up to 90 postnatal days) ]
    Conjugated serum bilirubin >1 mg/dl (34 mmol/L) (Moyer, 2004).


Secondary Outcome Measures :
  1. Severity of cholestasis [ Time Frame: From recruitment to full enteral feeding per mouth (up to 90 postnatal days) ]
    The severity of cholestasis was evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT).



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neonates admitted in the NICU,
  • gestational age of 34 weeks or over,
  • undergoing corrective surgery of congenital anomaly of the digestive tract or indirectly affecting the digestive tract (eg, diaphragmatic hernia)
  • initiation of PN with ILE within the first 48 hours after birth.

Exclusion Criteria:

  • pre-natal or early neonatal (within the first 72 hours after birth) diagnoses of congenital or acquired hepato-biliary disease, such as biliary atresia, choledochal cyst, inborn errors of metabolism, intra-hepatic familial cholestasis, infectious hepatitis, neonatal idiopathic hepatitis, biliary lithiasis and abnormalities of liver function tests .
  • later neonatal diagnoses of any above mentioned pathology.
  • other congenital conditions affecting the liver function, such as meconium ileus associated with cystic fibrosis.
  • treatment with ursodeoxycholic acid,
  • interruption of PN for more than 48 hours for any reason, except for the postsurgical period after corrective surgery of the main condition,
  • transference to another unit before completing 7 days of PN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633384


Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Investigators
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Principal Investigator: Luis Pereira-da-Silva, MD, PhD Neonatal Intensive Care Unit, Hospital Dona Estefania, Centro Hospitalar de Lisboa Central

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luís Pereira-da-Silva, MD, PhD, Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT02633384     History of Changes
Other Study ID Numbers: CHLC.CI70.2014
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luís Pereira-da-Silva, Centro Hospitalar de Lisboa Central:
Parenteral nutrition associated cholestasis
Intravenous lipid emulsions
Surgical neonates
Congenital gastrointestinal abnormalities
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Sorbitol
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Cathartics
Gastrointestinal Agents