Vitamin E for Extremely Preterm Infants
Ключевые слова
абстрактный
Описание
Intraventricular hemorrhage (IVH) -- bleeding into the brain's ventricular system -- is one of the most common complications of prematurity, affecting an estimated 10-40% of very low birth weight (<1500 g) infants born at less than 35 weeks of gestation. Mortality from severe (high-grade) IVH is 27-50%. Severe IVH can result in developmental delays and life-long neurological deficits, including cerebral palsy and seizures.
A number of strategies have been used in efforts to prevent IVH, including: antenatal corticosteroids, maternal vitamin K, delayed clamping of the umbilical cord, indomethacin, ethamsylate, inositol, and muscle paralysis. With the exception of antenatal corticosteroids and indomethacin, these measures have met with only limited success. Supplemental vitamin E, given in the first few hours of life to all premature infants, offers a promising low-risk approach to preventing and/or lessening the severity of IVH.
This safety and efficacy pilot trial will examine whether one dose of vitamin E (dl-α-tocopheryl acetate), given intragastrically to preterm infants <27 weeks gestation and <1000 grams birth weight, will produce blood serum α-tocopherol levels in the target range of 1-3 mg/dl. Based on the results of this pilot, a Phase III randomized control trial will be developed to test whether a single dose of vitamin E can reduce the incidence of death or neurodevelopmental impairment at 18-22 months corrected age in these preterm infants.
Most intraventricular hemorrhages occur in the first 72 hours after birth. Because of this, to prevent IVH, it must be given as soon as possible after birth. Eligible, consented infants will be assigned to either a vitamin E group or a placebo group. Infants in the vitamin E group will receive 1.0 ml/kg of dl-α-tocopheryl acetate (Aquasol E®); infants in the placebo control group will receive a similar amount of sterile water. The dose will be given within 4 hours of birth via a tube into the stomach. Blood samples will be taken from all infants before the dose is given, 24 hours after dosing, and 7 days after dosing to measure how well the vitamin E is absorbed into the bloodstream.
Даты
| Последняя проверка: | 10/31/2015 |
| Первый отправленный: | 08/30/2010 |
| Предполагаемая регистрация отправлена: | 08/30/2010 |
| Первое сообщение: | 08/31/2010 |
| Последнее обновление отправлено: | 11/09/2015 |
| Последнее обновление опубликовано: | 11/10/2015 |
| Фактическая дата начала исследования: | 09/30/2010 |
| Предполагаемая дата завершения начальной школы: | 07/31/2011 |
| Предполагаемая дата завершения исследования: | 07/31/2011 |
Состояние или болезнь
Вмешательство / лечение
Drug: Vitamin E
Drug: Placebo
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Experimental: Vitamin E A single intragastric dose of dl-α-tocopheryl acetate (Aquasol E®) 50 IU/kg. | Drug: Vitamin E A single intragastric dose of dl-α-tocopheryl acetate 50 IU/kg. |
| Placebo Comparator: Placebo Sterile water in volume equal to that of the comparator drug. | Drug: Placebo Sterile water in volume equal to that of the comparator drug |
Критерии приемлемости
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: - Less than 27 completed weeks gestational age - Birth weight less than 1,000 grams - Inborn infants Exclusion Criteria: - Infant's treatment will be limited based on poor prognosis - Umbilical cord or blood pH below 7.0 - Antenatally diagnosed brain abnormality, including hemorrhage - Major congenital malformations, including those for which feeding is contraindicated - Mother of infant enrolled in a clinical trial of vitamin E supplementation - Mother of infant reports self administration of monovitamin supplements of vitamin E during pregnancy or labor - Infant has received supplemental vitamin E (except multivitamin additive in parenteral nutrition or through enteral milk or formula feeds) - Greater than four hours of age |
Результат
Основные показатели результатов
1. Serum tocopherol levels [Birth to 7 days]
