The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants

NCT03730883 | Unknown

• 1 other identifier: CLAG'18
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 4

Brief Summary

This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants. Half of participants will have a central line removed at ≥100 ml/kg/d, while the other half will have a central line removed at ≥ 140 ml/kg/day.

Conditions

Growth Failure; CLABSI - Central Line Associated Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Weight at 36 weeks PMA.

  Difference between the two intervention arms in weight at 36 weeks PMA. Noninferiority would be declared if a mean difference in weight at 36 weeks PMA will be no more than 210 g.

  36 weeks PMA.

Secondary Outcomes (10)

• Head circumference at 36 weeks PMA.

  36 weeks PMA.

• Length at 36 weeks PMA.

  36 weeks PMA.

• The rate of CLABSI.

  From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.

• Time to regain birth weight.

  Up to 4 weeks.

• Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.

  Up to 7 days post-intervention.

Other Outcomes (7)

• Growth velocity.

  From birth to 36 weeks' PMA.

• Z-score for weight at birth.

  Through study completion, an average of 4 months.

• Z-score for head circumference at birth.

  Through study completion, an average of 4 months.

Study Arms (2)

Central line removal at 100ml/kg/day.

EXPERIMENTAL

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.

Procedure: Central line removal at 100ml/kg/day.

Central line removal at 140 ml/kg/day.

ACTIVE COMPARATOR

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.

Procedure: Central line removal at 140ml/kg/day.

Interventions

Central line removal at 100ml/kg/day. PROCEDURE

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 100ml/kg/day.

Central line removal at 140ml/kg/day. PROCEDURE

In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.

Central line removal at 140 ml/kg/day.

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight ≤ 1500 g (very low birth weight).
• Birth weight ≥ 3rd percentile at a given gestational age.
• Central line inserted (PICC or UVC).
• Oral intake not exceeding 100 ml/kg/d at randomization.
• Lack of congenital illness or malformation that may affect growth.
• Signed parental consent.

You may not qualify if:

• Birth weight \> 1500 g.
• Birth weight \< 3rd percentile at a given gestational age.
• The absence of a central line.
• Oral intake ≥100 ml/kg/d at randomization.
• Congenital illness or malformation that may affect growth.
• Lack of informed consent.
• Participation in other intervention (investigational) trials, that may affect the primary outcome.

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead
• Nutricia Foundation: collaborator

Study Sites (4)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

Location

Department of Reproductive Health, Centre of Postgraduate Medical Education

Warsaw, 01-004, Poland

Location

Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw

Warsaw, 02-015, Poland

Location

Department of Neonatology, Wroclaw Medical University

Wroclaw, 50-556, Poland

Location

Related Publications (14)

• Poindexter B. Approaches to growth faltering. World Rev Nutr Diet. 2014;110:228-38. doi: 10.1159/000358471. Epub 2014 Apr 11.

  PMID: 24751633 BACKGROUND

• 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.

  PMID: 20231192 BACKGROUND

• 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.

  PMID: 19403500 BACKGROUND

• 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.

  PMID: 14510321 BACKGROUND

• 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.

  PMID: 16585322 BACKGROUND

• 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.

  PMID: 15167885 BACKGROUND

• 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.

  PMID: 15547163 BACKGROUND

• 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.

  PMID: 24355942 BACKGROUND

• 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.

  PMID: 22836823 BACKGROUND

• 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.

  PMID: 21511081 BACKGROUND

• 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.

  PMID: 24218474 BACKGROUND

• 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.

  PMID: 24249819 BACKGROUND

• 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.

  PMID: 18829797 BACKGROUND

• 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.

  PMID: 31530607 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justyna Romanska, MD

  Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: January 26, 2019
• Primary Completion: April 10, 2022
• Study Completion: February 1, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who provides a methodologically sound proposal.

Locations

PL (4)