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

Princess Anna Mazowiecka Hospital, Warsaw, Poland214 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

214

Conditions

Growth Failure CLABSI - Central Line Associated Bloodstream Infection

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 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.

Eligibility

Sex: ALLMax age: 2 Weeks

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

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.

Time frame: 36 weeks PMA.

Secondary Outcomes

Head circumference at 36 weeks PMA.

Difference between the two intervention arms in head circumference at 36 weeks PMA.

Time frame: 36 weeks PMA.

Length at 36 weeks PMA.

Difference between the two intervention arms in length at 36 weeks PMA.

Time frame: 36 weeks PMA.

The rate of CLABSI.

The rate of CLA-BSI in both groups.

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

Time to regain birth weight.

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.

Time frame: Up to 4 weeks.

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

Safety of early central line removal will be assessed in respect to number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.

Time frame: Up to 7 days post-intervention.

Central line insertion due to feeding intolerance.

Need for central line insertion within 7 days following intervention because of feeding intolerance.

Data from ClinicalTrials.gov

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