The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
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| ClinicalTrials.gov Identifier: NCT03730883 |
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Recruitment Status :
Active, not recruiting
First Posted : November 5, 2018
Last Update Posted : July 6, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Growth Failure CLABSI - Central Line Associated Bloodstream Infection | Procedure: Central line removal at 100ml/kg/day. Procedure: Central line removal at 140ml/kg/day. | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 214 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | January 26, 2019 |
| Actual Primary Completion Date : | April 10, 2022 |
| Estimated Study Completion Date : | February 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Central line removal at 100ml/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. |
Procedure: Central line removal at 100ml/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. |
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Active Comparator: Central line removal at 140 ml/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 140 ml/kg/day of enteral intake if well tolerated. |
- Weight at 36 weeks PMA. [ Time Frame: 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.
- Head circumference at 36 weeks PMA. [ Time Frame: 36 weeks PMA. ]Difference between the two intervention arms in head circumference at 36 weeks PMA.
- Length at 36 weeks PMA. [ Time Frame: 36 weeks PMA. ]Difference between the two intervention arms in length at 36 weeks PMA.
- The rate of CLABSI. [ Time Frame: From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1. ]The rate of CLA-BSI in both groups.
- Time to regain birth weight. [ Time Frame: Up to 4 weeks. ]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.
- Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition. [ Time Frame: Up to 7 days post-intervention. ]Safety of early central line removal will be assessed in respect to number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.
- Central line insertion due to feeding intolerance. [ Time Frame: Up tp 7 days post-intervention. ]Need for central line insertion within 7 days following intervention because of feeding intolerance.
- Weight at 18 to 22 months corrected age (CA). [ Time Frame: 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.
- Length at 18 to 22 months corrected age (CA). [ Time Frame: 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.
- Head circumference at 18 to 22 months corrected age (CA). [ Time Frame: 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.
- Length of hospital stay. [ Time Frame: Through study completion, an average of 2 years. ]The data on the length of hospital stay expressed in days will be recorded.
- Growth velocity. [ Time Frame: From birth to 36 weeks' PMA. ]Growth velocity will be calculated using exponential method. This outcome will be assessed for noniferiority.
- Z-score for weight at birth. [ Time Frame: Through study completion, an average of 4 months. ]Z-scores for weight at birth will be compared between the two study groups. We will use Fenton 2013 dataset to determine Z-scores.
- Z-score for head circumference at birth. [ Time Frame: Through study completion, an average of 4 months. ]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.
- Z-score for weight at 36 weeks' PMA. [ Time Frame: Through study completion, an average of 4 months. ]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.
- Z-score for head circumference at 36 weeks' PMA. [ Time Frame: Through study completion, an average of 4 months. ]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.
- Change in Z-score for weight from birth to 36 weeks' PMA. [ Time Frame: Through study completion, an average of 4 months. ]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.
- Change in Z-score for head circumference from birth to 36 weeks' PMA. [ Time Frame: Through study completion, an average of 4 months. ]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.
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| Ages Eligible for Study: | up to 2 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730883
| Poland | |
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | |
| Warsaw, Poland, 00-315 | |
| Department of Reproductive Health, Centre of Postgraduate Medical Education | |
| Warsaw, Poland, 01-004 | |
| Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw | |
| Warszawa, Poland, 02-015 | |
| Department of Neonatology, Wroclaw Medical University | |
| Wroclaw, Poland, 50-556 | |
| Principal Investigator: | Justyna Romanska, MD | Department of Neonatology and Neonatal Intensive Care Warsaw Medical University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Princess Anna Mazowiecka Hospital, Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT03730883 |
| Other Study ID Numbers: |
CLAG'18 |
| First Posted: | November 5, 2018 Key Record Dates |
| Last Update Posted: | July 6, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 Materials: |
Study Protocol |
| Time Frame: | Immediately following publication. No end date. |
| Access Criteria: | Anyone who provides a methodologically sound proposal. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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