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

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ClinicalTrials.gov Identifier: NCT03730883
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Nutricia Foundation
Information provided by (Responsible Party):
Princess Anna Mazowiecka Hospital, Warsaw, Poland

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.

Condition or disease Intervention/treatment Phase
Growth Failure CLABSI - Central Line Associated Bloodstream Infection Procedure: Central line removal at 100ml/kg/day. Procedure: Central line removal at 140ml/kg/day. Not Applicable

Detailed Description:

Eligible infants will be randomized in equal proportions between two groups. In the first group (group A - early central line removal) central line will be removed at the time the infant reaches 100 ml/kg/d of enteral intake. In the second group (group B - standard central line removal) central line will be removed at the time the infant reaches 140 ml/kg/d of enteral intake (full 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:

  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial
Actual Study Start Date : January 26, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Procedure: 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.

Active Comparator: 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.

Procedure: 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.




Primary Outcome Measures :
  1. Weight at 36 weeks PMA. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Head circumference at 36 weeks PMA. [ Time Frame: 36 weeks PMA. ]
    Difference between the two intervention arms in head circumference at 36 weeks PMA.

  2. Length at 36 weeks PMA. [ Time Frame: 36 weeks PMA. ]
    Difference between the two intervention arms in length at 36 weeks PMA.

  3. The rate of CLABSI. [ Time Frame: From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1. ]
    The rate of CLA-BSI in both groups.

  4. Time to regain birth weight. [ Time Frame: Up to 4 weeks. ]
    If the infants remain above their birth weight for 3 consecutive days, the first day of the 3 weights will be used as the date of regaining birth weight.

  5. Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition. [ Time Frame: Up to 7 days post-intervention. ]
    Safety of early central line removal will be assessed in respect to number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.

  6. Central line insertion due to feeding intolerance. [ Time Frame: Up tp 7 days post-intervention. ]
    Need for central line insertion within 7 days following intervention because of feeding intolerance.

  7. Weight at 18 to 22 months corrected age (CA). [ Time Frame: At 18 to 22 months corrected age (CA). ]
    Weight at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.

  8. Length at 18 to 22 months corrected age (CA). [ Time Frame: At 18 to 22 months corrected age (CA) ]
    Length at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.

  9. Head circumference at 18 to 22 months corrected age (CA). [ Time Frame: At 18 to 22 months corrected age (CA). ]
    Head circumference at the age of 18 to 22 months corrected age (CA) will be assessed for noninferiority.

  10. Length of hospital stay. [ Time Frame: Through study completion, an average of 2 years. ]
    The data on the length of hospital stay expressed in days will be recorded.



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Birth weight ≤ 1500 g (very low birth weight).
  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:

  1. Birth weight > 1500 g.
  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.

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): NCT03730883


Contacts
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Contact: Justyna o Romanska, MD +48225830340 ext +48225830340 justyna_romanska@gazeta.pl
Contact: Joanna Seliga-Siwecka, MD PhD +48225966155 seliga.joanna@gmail.com

Locations
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Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University Recruiting
Warsaw, Poland, 00-315
Contact: Justyna Romanska, MD    +48225966155    justyna_romanska@gazeta.pl   
Contact: Joanna Seliga-Siwecka, MD PhD    +48225966155    seliga.joanna@gmail.com   
Department of Reproductive Health, Centre of Postgraduate Medical Education Recruiting
Warsaw, Poland, 01-004
Contact: Natalia Brunets, MD    506213615 ext +48    brunat1108@gmail.com   
Contact: Ewa Adamska, MD, PhD    606490114 ext +48    eva.adamska@wp.pl   
Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw Recruiting
Warszawa, Poland, 02-015
Contact: Justyna Romańska, MD    +48225830340    justyna_romanska@gazeta.pl   
Contact: Justyna Romańska, MD    +48225830336    justyna_romanska@gazeta.pl   
Department of Neonatology, Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-556
Contact: Izabela Lehman, MD    +48694893556    cygan.iza@gmail.com   
Contact: Barbara Królak-Olejnik, Prof.    +48717331500    WL-30@umed.wroc.pl   
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Nutricia Foundation
Investigators
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Principal Investigator: Justyna Romanska, MD Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Princess Anna Mazowiecka Hospital, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03730883    
Other Study ID Numbers: CLAG'18
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
Supporting Materials: Study Protocol
Time Frame: Immediately following publication. No end date.
Access Criteria: Anyone who provides a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Birth Weight
Failure to Thrive
Body Weight
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes