An interventional study of Central line removal at 100ml/kg/day. and Central line removal at 140ml/kg/day. in Growth Failure and CLABSI - Central Line Associated Bloodstream Infection, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Status unknown at 4 sites in Poland. Open to participants aged Up to 2 Weeks. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Not applicable, Interventional, and Prevention
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:
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 214 is above the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 100 ml/kg/day of enteral intake if well tolerated.
In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.
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.
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.
Time frame: Up tp 7 days post-intervention.
Weight 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.
Time frame: At 18 to 22 months corrected age (CA).
Length 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.
Time frame: At 18 to 22 months corrected age (CA)
Head circumference 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.
Time frame: At 18 to 22 months corrected age (CA).
Length of hospital stay.
The data on the length of hospital stay expressed in days will be recorded.
Time frame: Through study completion, an average of 2 years.
Growth velocity.
Growth velocity will be calculated using exponential method. This outcome will be assessed for noniferiority.
Time frame: From birth to 36 weeks' PMA.
Z-score for weight at birth.
Z-scores for weight at birth will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
Time frame: Through study completion, an average of 4 months.
Z-score for head circumference at birth.
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.
Time frame: Through study completion, an average of 4 months.
Z-score for weight at 36 weeks' PMA.
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.
Time frame: Through study completion, an average of 4 months.
Z-score for head circumference at 36 weeks' PMA.
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.
Time frame: Through study completion, an average of 4 months.
Change in Z-score for weight from birth to 36 weeks' PMA.
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.
Time frame: Through study completion, an average of 4 months.
Change in Z-score for head circumference from birth to 36 weeks' PMA.
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.
Time frame: Through study completion, an average of 4 months.
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: Immediately following publication. No end date.
Access criteria: Anyone who provides a methodologically sound proposal.
Ran from Jan 2019 to primary completion in Apr 2022, 38 months.
Of 18 interventional studies with no phase under Failure to Thrive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 38 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Princess Anna Mazowiecka Hospital, Warsaw, Poland