Interim Report: NeoVitaA study trial. Meyer S. 2016.
abstract   bibtex   
Background: Prematurity and the associated risk for bronchopulmonary dysplasia (BPD) remain a significant threat to extremely low birth weight (ELBW) infants. Vitamin A has been considered a therapeutic alternative in reducing the rate of BPD and mortality. To investigate whether early postnatal, additional high-dose oral vitamin A supplementation for 28 days is more efficient in reducing BPD or death in ELBW infants than placebo treatment. Objectives: To provide data on the current status of participating centers, number of included patients, and ongoing obstacles in realizing this pharmaceutical study in ELBW infants. Methods: This is an interim report of the multicenter, double-blind RCT comparing postnatal high-dose oral vitamin A supplementation (5,000 IU vitamin A/kg/day vs. placebo) for 28 days in ELBW neonates requiring mechanical ventilation, noninvasive ventilatory support or supplemental oxygen at 24 h of age. The primary end point is the proportion of children who died before 36 weeks gestational age or developed moderate or severe BPD. BPD is defined as the need for supplemental oxygen to maintain SaO2 of \textgreater92 % at rest at 36 weeks postmenstrual age (PMA). Clinical secondary end points include the following: BPD (including mild form), IVH, PVL, ROP, NEC, total number of days of mechanical ventilation and oxygen supplementation, and safety and tolerability of high-dose vitamin A supplementation. Logistic and organizational support is provided by the IZKS, Mainz. Results and conclusions: After trial start in March 2015, a total of 20 large neonatal centers in Germany are actively recruiting patients. As of January 2016, a total of 62 ELBW infants have been enrolled into the NeoVita A trial. Major problems that have been encountered during the initial phase are mostly related to organizational and medico-legal aspects. Tight financial budgets have been proven a relevant obstacle in recruiting a larger of number of participating centers.
@misc{meyer_s._interim_2016,
	title = {Interim {Report}: {NeoVitaA} study trial},
	abstract = {Background: Prematurity and the associated risk for bronchopulmonary dysplasia (BPD) remain a significant threat to extremely low birth weight (ELBW) infants. Vitamin A has been considered a therapeutic alternative in reducing the rate of BPD and mortality. To investigate whether early postnatal, additional high-dose oral vitamin A supplementation for 28 days is more efficient in reducing BPD or death in ELBW infants than placebo treatment. Objectives: To provide data on the current status of participating centers, number of included patients, and ongoing obstacles in realizing this pharmaceutical study in ELBW infants. Methods: This is an interim report of the multicenter, double-blind RCT comparing postnatal high-dose oral vitamin A supplementation (5,000 IU vitamin A/kg/day vs. placebo) for 28 days in ELBW neonates requiring mechanical ventilation, noninvasive ventilatory support or supplemental oxygen at 24 h of age. The primary end point is the proportion of children who died before 36 weeks gestational age or developed moderate or severe BPD. BPD is defined as the need for supplemental oxygen to maintain SaO2 of {\textgreater}92 \% at rest at 36 weeks postmenstrual age (PMA). Clinical secondary end points include the following: BPD (including mild form), IVH, PVL, ROP, NEC, total number of days of mechanical ventilation and oxygen supplementation, and safety and tolerability of high-dose vitamin A supplementation. Logistic and organizational support is provided by the IZKS, Mainz. Results and conclusions: After trial start in March 2015, a total of 20 large neonatal centers in Germany are actively recruiting patients. As of January 2016, a total of 62 ELBW infants have been enrolled into the NeoVita A trial. Major problems that have been encountered during the initial phase are mostly related to organizational and medico-legal aspects. Tight financial budgets have been proven a relevant obstacle in recruiting a larger of number of participating centers.},
	journal = {Monatsschrift fur Kinderheilkunde},
	author = {{Meyer S.}},
	year = {2016},
	keywords = {Child, Germany, Pharmacokinetics, arterial oxygen saturation, artificial ventilation, assisted ventilation, budget, clinical trial, controlled clinical trial, controlled study, death, disease course, double blind procedure, drug megadose, extremely low birth weight, gestational age, human, legal aspect, lung dysplasia, major clinical study, multicenter study, newborn, oxygen, placebo, rest, retinol, safety}
}
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