UnknownNot Applicable

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

Poland214 participantsStarted 2019-01-26

Plain-language 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.

Who can participate

Age range2 Weeks

SexALL

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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.

What they're measuring

Weight at 36 weeks PMA.

Timeframe: 36 weeks PMA.

Trial details

NCT IDNCT03730883

SponsorPrincess Anna Mazowiecka Hospital, Warsaw, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-10

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