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A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial.

ABSTRACT: To determine the optimal dose of vitamin D supplementation to achieve biochemical vitamin D sufficiency in extremely low gestational age newborns in a masked randomized controlled trial.100 infants 23 0/7-27 6/7 weeks gestation were randomized to vitamin D intakes of placebo (n = 36), 200 IU (n = 34), and 800 IU/d (n = 30) (approximating 200, 400, or 1000 IU/d, respectively, when vitamin D routinely included in parenteral or enteral nutrition is included). The primary outcomes were serum 25-hydroxy vitamin D concentrations on postnatal day 28 and the number of days alive and off respiratory support in the first 28 days.At birth, 67% of infants had 25-hydroxy vitamin D <20 ng/mL suggesting biochemical vitamin D deficiency. Vitamin D concentrations on day 28 were (median [25th-75th percentiles], ng/mL): placebo: 22 (13-47), 200 IU: 39 (26-57), 800 IU: 84.5 (52-99); P < .001. There were no differences in days alive and off respiratory support (median [25th-75th percentiles], days): placebo: 1 (0-11), 200 IU: 0 (0-8), and 800 IU: 0.5 (0-22); P = .63, or other respiratory outcomes among groups.At birth, most extremely preterm infants have biochemical vitamin D deficiency. This biochemical deficiency is reduced on day 28 by supplementation with 200 IU/d and prevented by 800 IU/d. Larger trials are required to determine if resolution of biochemical vitamin D deficiency improves clinical outcomes.ClinicalTrials.gov: NCT01600430.

SUBMITTER: Fort P

PROVIDER: S-EPMC4925243 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial.

Fort Prem P Salas Ariel A AA Nicola Teodora T Craig Carolyne M CM Carlo Waldemar A WA Ambalavanan Namasivayam N

The Journal of pediatrics 20160411

<h4>Objective</h4>To determine the optimal dose of vitamin D supplementation to achieve biochemical vitamin D sufficiency in extremely low gestational age newborns in a masked randomized controlled trial.<h4>Study design</h4>100 infants 23 0/7-27 6/7 weeks gestation were randomized to vitamin D intakes of placebo (n = 36), 200 IU (n = 34), and 800 IU/d (n = 30) (approximating 200, 400, or 1000 IU/d, respectively, when vitamin D routinely included in parenteral or enteral nutrition is included). ...[more]

PMID: 27079965

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Project description:BackgroundDue to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth.ObjectiveThe aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants.DesignIn this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access.ResultsSixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups.ConclusionEarly progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

Project description:Objectives: To compare the clinical efficacy of heated, humidified high-flow nasal cannula (HHHFNC) and nasal continuous positive airway pressure (NCPAP) in extremely low-birth-weight preterm infants (ELBWI) after extubation. Methods: This trial included 94 extremely low-birth-weight infants (ELBWI), within 7 days after birth, and prepared for tracheal extubation and a change to non-invasive ventilation in the neonatal intensive care unit (NICU) admitted to our hospital from January 2015 to December 2018, with 48 infants in the HHHFNC group and 46 infants in the NCPAP group. Reintubation rate within 72 h after initial extubation, total ventilation time, non-invasive ventilation time, total oxygen inhalation time, and the time to reach full enteral feeding were the primary outcome measures. Total intestinal feeding time, average weight gain rate, days of hospitalization, costs of hospitalization, and complication rates, including nasal injury, IVH, BPD, NEC, ROP, and PDA, were used as secondary outcomes. Data were analyzed using Student's t-test or the Mann-Whitney U-test with a Chi-square test or Fisher's exact test, as appropriate, in SPSS (25.0). Results: HHHFNC not only shortened the oxygen exposure time but also effectively reduced the incidence of nasal injury (6.25 vs. 36.96%) and NEC (10.42 vs. 28.26%) (P < 0.05). Additionally, HHHFNC achieved a significant advance in the time to reach full enteral feeding (31.24 ± 11.35 vs. 34.21 ± 14.09 days); increased the average weight gain rate (16.07 ± 3.10 vs. 13.74 ± 4.21) and reduced the days of hospitalization (73.45 ± 18.84 vs. 79.24 ± 19.75), with a lower cost of hospitalization (16.04 ± 3.64 vs.18.79 ± 4.13) thousand dollars (all P < 0.05). Conclusions: Compared with NCPAP, HHHFNC was effective in preventing extubation failure in mechanically ventilated preterm ELBWI. HHHFNC shortens oxygen consumption time and significantly reduces the incidence of nasal injury and necrotizing enterocolitis; moreover, it can also reduce the length of stay and the hospitalization costs.

Project description:IntroductionThis study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position.Material and methodsA non-inferiority randomized parallel clinical trial. Kangaroo care will be performed in a lateral position for the experimental group and in a prone position for the control group preterm. The study will take place at the neonatal intensive care unit (NICU) of a University Hospital. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. The sample size calculated was 35 participants in each group. When the premature infant is hemodynamically stable and one of the parents stays in the NICU, the patient will be randomized into two groups: an experimental group or a control group. The primary outcome is premature infant axillary temperature. Neonatal pain level and intraventricular hemorrhage are secondary outcomes.DiscussionThere is no scientific evidence on modified kangaroo care lateral position. Furthermore, there is little evidence of increased intraventricular hemorrhage association with the lateral head position necessary in conventional or prone kangaroo care in extremely premature newborns. Kangaroo care is a priority intervention in neonatal units increasing the time of use more and more, making postural changes necessary to optimize comfort and minimize risks with kangaroo care lateral position as an alternative to conventional prone position kangaroo care. Meanwhile, it is essential to ensure that the conventional kangaroo care prone position, which requires the head to lay sideways, is a safe position in terms of preventing intraventricular hemorrhage in the first five days of life of children under 28 weeks of gestational age. Trial registration at clinicaltrials.gov: NCT03990116.

Project description:IntroductionThe mortality rate of extremely low gestational age (ELGA) (born <gestational week 28+0) infants remains high, and severe infections and necrotising enterocolitis (NEC) are common causes of death. Preterm infants receiving human milk have lower incidence of sepsis and NEC than those fed a bovine milk-based preterm formula. Despite this, fully human milk fed ELGA infants most often have a significant intake of cow's milk protein from bovine-based protein fortifier. The aim of this study is to evaluate whether the supplementation of human milk-based, as compared with bovine-based, nutrient fortifier reduces the prevalence of NEC, sepsis and mortality in ELGA infants exclusively fed with human milk.Methods and analysisA randomised-controlled multicentre trial comparing the effect of a human breast milk-based fortifier with a standard bovine protein-based fortifier in 222-322 ELGA infants fed human breast milk (mother's own milk and/or donor milk). The infants will be randomised to either fortifier before reaching 100 mL/kg/day in oral feeds. The intervention, stratified by centre, will continue until the target postmenstrual week 34+0. The primary outcome is a composite of NEC, sepsis or death. Infants are characterised with comprehensive clinical and nutritional data collected prospectively from birth until hospital discharge. Stool, urine, blood and breast milk samples are collected for analyses in order to study underlying mechanisms. A follow-up focusing on neurological development and growth will be performed at 2 and 5.5 years of age. Health economic analyses will be made.Ethics and disseminationThe study is conducted according to ICH/GCP guidelines and is approved by the regional ethical review board in Linköping Sweden (Dnr 2018/193-31, Dnr 2018/384-32). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberThe study was registered with ClinicalTrials.gov NCT03797157, 9 January 2019.

Dataset Information

A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial.

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A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial.

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