RecruitingPhase 3ACTRN12612000823875

Zinc supplementation in very low birth weight neonates

Zinc supplementation and neonatal morbidity : a randomized, placebo-controlled study in very low birth weight neonates


Sponsor

“V.Betania” Evangelic Hospital of Naples

Enrollment

200 participants

Start Date

Feb 1, 2009

Study Type

Interventional

Conditions

Summary

There are many evidences that zinc may be essential for brain, pulmonary and intestinal development and function, as well as for growth, in the fetus and child. Preterm infants have a high risk of zinc deficiency. In this study we will aimed to investigate the efficacy of zinc supplementation in reducing morbidity of preterm neonates related to neurological, respiratory and intestinal complications.


Eligibility

Sex: Both males and femalesMin Age: 1 WeeksMax Age: 4 Weekss

Plain Language Summary

Simplified for easier understanding

This study tests whether giving zinc supplements to very premature babies (born early or very small) can reduce complications affecting the brain, lungs, and gut. Premature babies often have low zinc levels because they miss out on the zinc normally passed from the mother in the last weeks of pregnancy, which may affect their development. You may be eligible if: - Your baby was born weighing between 401 and 1,500 grams, OR - Your baby was born between 24 and 32 weeks of pregnancy - Your baby is in a neonatal intensive care unit (NICU) You may NOT be eligible if: - There are signs of infection present at birth - Your baby has an immune disorder, serious birth defect, or genetic condition - Your baby is critically ill (very low blood pH or prolonged oxygen deprivation) - Your baby is likely to leave the hospital within the first week Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Active treatment consist in zinc at dosage of 10 mg/d associated to other vitamins. We used commercial zinc preparation available on the market as drops. Treatment was started at 7 d of life until dis

Active treatment consist in zinc at dosage of 10 mg/d associated to other vitamins. We used commercial zinc preparation available on the market as drops. Treatment was started at 7 d of life until discharge from the hospital. Other vitamins contained in the preparation were (pro dose)folates (120 mcg), vit. B12 (0.6 mcg) and Vit D3 (400 UI), vit. C (60 mg), vit. E (6 mg), vit. A (480 mcg). To reach Recommended Dietary Allowance (RDA) for folates, vit. B12, D3, C, E, A, and B group, all subjects were supplemented daily with folates (56 mcg/Kg), vit B12 (0.3 mcg/Kg), vit. D3 (10 UI/Kg), vit. C (25 mg/Kg), E (2.8 mg/Kg), A (500 mcg/Kg), and B group (B1 0.35 mg/Kg, B2 0.15 mg/Kg, B6 0.18 mg/Kg, niacin 6.8 mg/Kg, and biotin 6 mcg) intravenously when in parenteral nutrition. When full enteral feeding was achieved the RDA for folates, vit B12, vit. D3, vit. C, E, A, and B group were reached in all subjects considering that preterm formula used during the study contained folates (30 mcg), vit B12 (0.2 mcg), vit. D3 (10 UI), vit. C (20 mg/Kg), E (2.4 mg), A (180 mcg), and B group (B1 0.19 mg/Kg, B2 0.30 mg/Kg, B6 0.135 mg/Kg, niacin 1.1 mg/Kg, and biotin 5.5 mcg) per 100 ml, and that all subject were supplemented daily with vit D3 (400 UI) per os. In this way, RDA for zinc was obtained only in the active treatment group.


Locations(1)

Italy

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ACTRN12612000823875