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

July 2, 2022 updated by: Princess Anna Mazowiecka Hospital, Warsaw, Poland

The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 00-315
        • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
      • Warsaw, Poland, 01-004
        • Department of Reproductive Health, Centre of Postgraduate Medical Education
      • Warszawa, Poland, 02-015
        • Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
      • Wroclaw, Poland, 50-556
        • Department of Neonatology, Wroclaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 weeks PMA.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head circumference at 36 weeks PMA.
Time Frame: 36 weeks PMA.
Difference between the two intervention arms in head circumference at 36 weeks PMA.
36 weeks PMA.
Length at 36 weeks PMA.
Time Frame: 36 weeks PMA.
Difference between the two intervention arms in length at 36 weeks PMA.
36 weeks PMA.
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.
From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.
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.
Up to 4 weeks.
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.
Up to 7 days post-intervention.
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.
Up tp 7 days post-intervention.
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.
At 18 to 22 months corrected age (CA).
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.
At 18 to 22 months corrected age (CA)
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.
At 18 to 22 months corrected age (CA).
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.
Through study completion, an average of 2 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth velocity.
Time Frame: From birth to 36 weeks' PMA.
Growth velocity will be calculated using exponential method. This outcome will be assessed for noniferiority.
From birth to 36 weeks' PMA.
Z-score for weight at birth.
Time Frame: Through study completion, an average of 4 months.
Z-scores for weight at birth will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.
Z-score for head circumference at birth.
Time Frame: Through study completion, an average of 4 months.
Z-scores for head circumference at birth will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.
Z-score for weight at 36 weeks' PMA.
Time Frame: Through study completion, an average of 4 months.
Z-scores for weight at 36 weeks' PMA will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.
Z-score for head circumference at 36 weeks' PMA.
Time Frame: Through study completion, an average of 4 months.
Z-scores for head circumference at 36 weeks' PMA will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.
Change in Z-score for weight from birth to 36 weeks' PMA.
Time Frame: Through study completion, an average of 4 months.
Changes in Z-scores for weight from birth to 36 weeks' PMA will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.
Change in Z-score for head circumference from birth to 36 weeks' PMA.
Time Frame: Through study completion, an average of 4 months.
Changes in Z-scores for head circumference from birth to 36 weeks' PMA will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Through study completion, an average of 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Collaborators

Nutricia Foundation

Investigators

  • Principal Investigator: Justyna Romanska, MD, Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2019

Primary Completion (ACTUAL)

April 10, 2022

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (ACTUAL)

November 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 2, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAG'18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who provides a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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