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

Growth Failure Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03730883
• Other study ID #: CLAG'18
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2022
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: February 1, 2024
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• CLABSI - Central Line Associated Bloodstream Infection
• Failure to Thrive
• Growth Failure
• Sepsis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw
Poland	Department of Reproductive Health, Centre of Postgraduate Medical Education	Warsaw
Poland	Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw	Warszawa
Poland	Department of Neonatology, Wroclaw Medical University	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland	Nutricia Foundation

Country where clinical trial is conducted

Poland, 

References & Publications (13)

Alshaikh B, Yee W, Lodha A, Henderson E, Yusuf K, Sauve R. Coagulase-negative staphylococcus sepsis in preterm infants and long-term neurodevelopmental outcome. J Perinatol. 2014 Feb;34(2):125-9. doi: 10.1038/jp.2013.155. Epub 2013 Dec 19. — View Citation

Donovan EF, Sparling K, Lake MR, Narendran V, Schibler K, Haberman B, Rose B, Meinzen-Derr J; Ohio Perinatal Quality Collaborative. The investment case for preventing NICU-associated infections. Am J Perinatol. 2013 Mar;30(3):179-84. doi: 10.1055/s-0032-1322516. Epub 2012 Jul 26. — View Citation

Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282. — View Citation

Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. Review. — View Citation

Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. — View Citation

Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18. — View Citation

Ibrahim HM, Jeroudi MA, Baier RJ, Dhanireddy R, Krouskop RW. Aggressive early total parental nutrition in low-birth-weight infants. J Perinatol. 2004 Aug;24(8):482-6. — View Citation

Milstone AM, Reich NG, Advani S, Yuan G, Bryant K, Coffin SE, Huskins WC, Livingston R, Saiman L, Smith PB, Song X. Catheter dwell time and CLABSIs in neonates with PICCs: a multicenter cohort study. Pediatrics. 2013 Dec;132(6):e1609-15. doi: 10.1542/peds.2013-1645. Epub 2013 Nov 11. — View Citation

O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. — View Citation

Poindexter B. Approaches to growth faltering. World Rev Nutr Diet. 2014;110:228-38. doi: 10.1159/000358471. Epub 2014 Apr 11. Review. — View Citation

Sengupta A, Lehmann C, Diener-West M, Perl TM, Milstone AM. Catheter duration and risk of CLA-BSI in neonates with PICCs. Pediatrics. 2010 Apr;125(4):648-53. doi: 10.1542/peds.2009-2559. Epub 2010 Mar 15. — View Citation

Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211. — View Citation

Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth velocity.	Growth velocity will be calculated using exponential method. This outcome will be assessed for noniferiority.	From birth to 36 weeks' PMA.
Other	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.	Through study completion, an average of 4 months.
Other	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.	Through study completion, an average of 4 months.
Other	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.	Through study completion, an average of 4 months.
Other	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.	Through study completion, an average of 4 months.
Other	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.	Through study completion, an average of 4 months.
Other	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.	Through study completion, an average of 4 months.
Primary	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.	36 weeks PMA.
Secondary	Head circumference at 36 weeks PMA.	Difference between the two intervention arms in head circumference at 36 weeks PMA.	36 weeks PMA.
Secondary	Length at 36 weeks PMA.	Difference between the two intervention arms in length at 36 weeks PMA.	36 weeks PMA.
Secondary	The rate of CLABSI.	The rate of CLA-BSI in both groups.	From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.
Secondary	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.	Up to 4 weeks.
Secondary	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.	Up to 7 days post-intervention.
Secondary	Central line insertion due to feeding intolerance.	Need for central line insertion within 7 days following intervention because of feeding intolerance.	Up tp 7 days post-intervention.
Secondary	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.	At 18 to 22 months corrected age (CA).
Secondary	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.	At 18 to 22 months corrected age (CA)
Secondary	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.	At 18 to 22 months corrected age (CA).
Secondary	Length of hospital stay.	The data on the length of hospital stay expressed in days will be recorded.	Through study completion, an average of 2 years.

External Links

•   Centers for Disease Control and Prevention. Central Line-Associated Bloodstream Infection (CLABSI) Event.
•   IHI - How-to Guide: Prevent Central Line-Associated Bloodstream Infections. Cambridge, MA: Institute for Healthcare Improvement; 2012
•   International Fetal and Newborn Growth Standards for the 21st Century. Anthropometry Handbook. University of Oxford; 2012
•   Nutritional Support of the Very Low Birth Weight Infant. Toolkit Rev.2018.