The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
About this trial
This is an interventional prevention trial for Growth Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
- Department of Reproductive Health, Centre of Postgraduate Medical Education
- Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
- Department of Neonatology, Wroclaw Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Central line removal at 100ml/kg/day.
Central line removal at 140 ml/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.
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.