The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
NCT ID: NCT03730883
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
214 participants
INTERVENTIONAL
2019-01-26
2024-02-01
Brief Summary
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Detailed Description
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* necessity of administration of drugs that must be given via central venous access,
* necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access,
* necessity of prolonged (\> 7 days) administration of drugs that must be given intravenously,
* necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access.
Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in group A will continue to receive parenteral nutrition via peripheral venous access at the discretion of the physician taking care for the infant. The solution used to continue parenteral nutrition via peripheral venous access will contain at maximum 2,5% amino acids, 10% glucose and no calcium or phosphate preparations to ensure fluid's osmolality will not exceed 900 mOsm/l and the solution will be well tolerated when administered via peripheral vein.
Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Central line removal at 100ml/kg/day.
In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present.
Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in this group may continue to receive parenteral nutrition via peripheral venous access, depending on the decision of the physician taking care for the infant.
Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.
Central line removal at 100ml/kg/day.
In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake if well tolerated.
Central line removal at 140 ml/kg/day.
In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake (full enteral intake). In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake. Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present.
Assessment of feedings tolerance will be at discretion of the physician taking care for the infant.
Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.
Central line removal at 140ml/kg/day.
In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.
Interventions
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Central line removal at 100ml/kg/day.
In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake if well tolerated.
Central line removal at 140ml/kg/day.
In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.
Eligibility Criteria
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Inclusion Criteria
2. Birth weight ≥ 3rd percentile at a given gestational age.
3. Central line inserted (PICC or UVC).
4. Oral intake not exceeding 100 ml/kg/d at randomization.
5. Lack of congenital illness or malformation that may affect growth.
6. Signed parental consent.
Exclusion Criteria
2. Birth weight \< 3rd percentile at a given gestational age.
3. The absence of a central line.
4. Oral intake ≥100 ml/kg/d at randomization.
5. Congenital illness or malformation that may affect growth.
6. Lack of informed consent.
7. Participation in other intervention (investigational) trials, that may affect the primary outcome.
2 Weeks
ALL
No
Sponsors
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Nutricia Foundation
OTHER
Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Principal Investigators
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Justyna Romanska, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Locations
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Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, , Poland
Department of Reproductive Health, Centre of Postgraduate Medical Education
Warsaw, , Poland
Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
Warsaw, , Poland
Department of Neonatology, Wroclaw Medical University
Wroclaw, , Poland
Countries
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References
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Poindexter B. Approaches to growth faltering. World Rev Nutr Diet. 2014;110:228-38. doi: 10.1159/000358471. Epub 2014 Apr 11.
Sengupta A, Lehmann C, Diener-West M, Perl TM, Milstone AM. Catheter duration and risk of CLA-BSI in neonates with PICCs. Pediatrics. 2010 Apr;125(4):648-53. doi: 10.1542/peds.2009-2559. Epub 2010 Mar 15.
Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.
Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.
Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.
Ibrahim HM, Jeroudi MA, Baier RJ, Dhanireddy R, Krouskop RW. Aggressive early total parental nutrition in low-birth-weight infants. J Perinatol. 2004 Aug;24(8):482-6. doi: 10.1038/sj.jp.7211114.
Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
Alshaikh B, Yee W, Lodha A, Henderson E, Yusuf K, Sauve R. Coagulase-negative staphylococcus sepsis in preterm infants and long-term neurodevelopmental outcome. J Perinatol. 2014 Feb;34(2):125-9. doi: 10.1038/jp.2013.155. Epub 2013 Dec 19.
Donovan EF, Sparling K, Lake MR, Narendran V, Schibler K, Haberman B, Rose B, Meinzen-Derr J; Ohio Perinatal Quality Collaborative. The investment case for preventing NICU-associated infections. Am J Perinatol. 2013 Mar;30(3):179-84. doi: 10.1055/s-0032-1322516. Epub 2012 Jul 26.
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
Milstone AM, Reich NG, Advani S, Yuan G, Bryant K, Coffin SE, Huskins WC, Livingston R, Saiman L, Smith PB, Song X. Catheter dwell time and CLABSIs in neonates with PICCs: a multicenter cohort study. Pediatrics. 2013 Dec;132(6):e1609-15. doi: 10.1542/peds.2013-1645. Epub 2013 Nov 11.
Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.
Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.
Romanska J, Margas W, Bokiniec R, Krajewski P, Seliga-Siwecka J. Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030167. doi: 10.1136/bmjopen-2019-030167.
Related Links
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IHI - How-to Guide: Prevent Central Line-Associated Bloodstream Infections. Cambridge, MA: Institute for Healthcare Improvement; 2012
International Fetal and Newborn Growth Standards for the 21st Century. Anthropometry Handbook. University of Oxford; 2012
Nutritional Support of the Very Low Birth Weight Infant. Toolkit Rev.2018.
Centers for Disease Control and Prevention. Central Line-Associated Bloodstream Infection (CLABSI) Event.
Other Identifiers
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CLAG'18
Identifier Type: -
Identifier Source: org_study_id
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