Clinical trial NCT03730883: The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth Failure
CLABSI - Central Line Associated Bloodstream Infection
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2018-11-05
Enrollment: 214
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Weight at 36 weeks PMA.
timeFrame: 36 weeks PMA.
Secondary outcomes:
measure: Head circumference at 36 weeks PMA.
timeFrame: 36 weeks PMA.
measure: Length at 36 weeks PMA.
timeFrame: 36 weeks PMA.
measure: The rate of CLABSI.
timeFrame: From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.
measure: Time to regain birth weight.
timeFrame: Up to 4 weeks.
measure: Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.
timeFrame: Up to 7 days post-intervention.
measure: Central line insertion due to feeding intolerance.
timeFrame: Up tp 7 days post-intervention.
measure: Weight at 18 to 22 months corrected age (CA).
timeFrame: At 18 to 22 months corrected age (CA).
measure: Length at 18 to 22 months corrected age (CA).
timeFrame: At 18 to 22 months corrected age (CA)
measure: Head circumference at 18 to 22 months corrected age (CA).
timeFrame: At 18 to 22 months corrected age (CA).
measure: Length of hospital stay.
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
measure: Growth velocity.
timeFrame: From birth to 36 weeks' PMA.
measure: Z-score for weight at birth.
timeFrame: Through study completion, an average of 4 months.
measure: Z-score for head circumference at birth.
timeFrame: Through study completion, an average of 4 months.
measure: Z-score for weight at 36 weeks' PMA.
timeFrame: Through study completion, an average of 4 months.
measure: Z-score for head circumference at 36 weeks' PMA.
timeFrame: Through study completion, an average of 4 months.
measure: Change in Z-score for weight from birth to 36 weeks' PMA.
timeFrame: Through study completion, an average of 4 months.
measure: Change in Z-score for head circumference from birth to 36 weeks' PMA.
timeFrame: Through study completion, an average of 4 months.
Locations:
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
city: Warsaw
country: Poland
facility: Department of Reproductive Health, Centre of Postgraduate Medical Education
city: Warszawa
country: Poland
facility: Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw
city: Wroclaw
country: Poland
facility: Department of Neonatology, Wroclaw Medical University
Study officials:
affiliation: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
name: Justyna Romanska, MD
role: PRINCIPAL_INVESTIGATOR
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