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

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Unknown

Conditions: Growth Failure; CLABSI - Central Line Associated Bloodstream Infection

Treatments: Procedure: Central line removal at 140ml/kg/day.; Procedure: Central line removal at 100ml/kg/day.

Study type: Interventional

Funder types: Other

Identifiers

NCT03730883

CLAG'18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Central line removal at 100ml/kg/day.

Experimental group

Description:

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.

Treatment:

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

Central line removal at 140 ml/kg/day.

Active Comparator group

Description:

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.

Treatment:

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