Randomized controlled trial of dexamethasone treatment in very-low-birth-weight infants with ventilator-dependent chronic lung disease

Objective This study aimed to study the role of oropharyngeal administration of colostrum (OAC) in very-low-birth-weight infants for reducing necrotizing enterocolitis (NEC). Study Design In this randomized controlled trial, 117 infants were enrolled, 59 were randomized to OAC group and 58 to routine care group. Infants with birth weight ≤ 1,250 g and/or gestational age ≤ 30 weeks were enrolled. Infants in OAC group received maternal colostrum (0.2 mL), 0.1 mL on either side, after 24 hours of postnatal life and were given every 2 hour for the next 72 hours irrespective of the enteral feeding status of the neonate. The primary outcome of the study was the incidence of NEC (stage 2 or 3). Results Baseline characteristics were comparable between the two groups. There was no significant reduction in the incidence of NEC in OAC group (0 [0%] vs. 3 [7.1%]; p = 0.11). There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days; p = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups. Conclusion OAC is safe and reduces the duration of hospital stay.

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Randomized Controlled Trial of Early Parenteral Nutrition Cycling to Prevent Cholestasis in Very Low Birth Weight Infants

The Journal of Pediatrics ◽

10.1016/j.jpeds.2012.02.003 ◽

2012 ◽

Vol 161 (2) ◽

pp. 229-233.e1 ◽

Cited By ~ 23

Author(s):

Agnes Salvador ◽

Michael Janeczko ◽

Rachel Porat ◽

Romal Sekhon ◽

Anja Moewes ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Low Birth Weight ◽

Parenteral Nutrition ◽

Very Low Birth Weight ◽

Controlled Trial ◽

Low Birth Weight Infants ◽

Randomized Controlled ◽

Early Parenteral Nutrition

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Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (≤ 32 weeks): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04841-x ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Joanna Seliga-Siwecka ◽

Anna Chmielewska ◽

Katarzyna Jasińska

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Low Birth Weight ◽

Human Milk ◽

Preterm Infants ◽

Very Low Birth Weight ◽

Controlled Trial ◽

Low Birth Weight Infants ◽

Randomized Controlled ◽

Link Type

Abstract Background Human milk is recommended for all very low birth weight infants. Breastmilk is highly variable in nutrient content, failing to meet the nutritional demands of this group. Fortification of human milk is recommended to prevent extrauterine growth retardation and associated poor neurodevelopmental outcome. However, standard fortification with fixed dose multicomponent fortifier does not account for the variability in milk composition. Targeted fortification is a promising alternative and needs further investigation. Methods This randomized controlled trial will recruit preterm infants (≤ 32 weeks of gestation) within the first 7 days of life. After reaching 80 ml/kg/day of enteral feeding, patients will be randomized to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialka, Nutricia—protein; Polycal, Nutricia—carbohydrates; Calogen, Nutricia—lipids). The intervention will continue until 37 weeks of post-conception age or hospital discharge. Parents and outcome assessors will be blinded to the intervention. The primary outcome measure is velocity of weight, length, and head growth until 36 weeks post-conceptional age or discharge. Secondary outcomes include neurodevelopment at 12 months assessed with Bayley Scale of Development III, repeated at 36 months; body composition at discharge and at 4 months; and incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity, and bronchopulmonary dysplasia. Discussion Targeted fortification has previously been shown as doable in the neonatal intensive care unit context. If it shows to improve growth and neonatal outcome, choosing the targeted fortification as a first line nutritional approach in very low birth weight infants may become a recommendation. Trial registration ClinicalTrials.govNCT03775785, Registered on July 2019.

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