Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
试验速览
- 阶段
- 4 期
- 入组人数
- 364
- 主要终点
- Body Length
研究概览
简要总结
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections.
Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group.
Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis.
Zinc is one of the micronutrients which is very risky for deficiency in premature babies.
Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased.
The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.
详细描述
Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room.
Infant in the intervention group was given elemental zinc supplementation once daily orally compared to placebo in the control group, at 3 days of age until the patient returned home or a maximum of 40 weeks' gestation.
The intervention group was given 10 mg elemental zinc once daily orally compared to placebo in the control group, at 3 days of age and received oral nutrition> 20cc / kg/ day, continued during treatment until the patient returned home or a maximum of 40 weeks' gestation.
Monitored infant development indicators, measured once a week. Monitoring of the incidence of infection in late-onset infants in clinical and laboratory settings according to the existing hospital settings.
The monitoring of NEC events in all research subjects was carried out. Screening ROP at the age of 3 weeks and/or when the baby is going home. The participants were observed to be allowed to go home or a maximum of 40 weeks' gestation if they were still being treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization is carried out by research assistants, then making sequential numbers with closed envelopes that have been prepared. The results of the randomization are only known by research assistants. At the age of 3 days or priming> 20cc / kg body weight/day, the research assistant will give a bottle of medicine containing zinc/placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse. The researcher monitors all patients who are sampled without knowing which group is the test and which group is the control.
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm (gestational age of 28 - 32 weeks)
- •Newborns with a ratio of body weight and gestational age: Small for Gestational Age or Large for Gestational Age
- •Get parental approval to be included in the study by signing an informed consent
排除标准
- •Newborns with severe congenital abnormalities
- •Newborns with digestive tract abnormalities: partial, total obstruction or gastrointestinal atresia
- •Newborns with unstable hemodynamic conditions that will affect the survival rate
- •Mothers who consume alcohol regularly (≧ 2x a month) during pregnancy
- •Newborns with early-onset sepsis
研究组 & 干预措施
Treatment Group
Participants who receive the intervention.
干预措施: Zinc Sulfate (Drug)
Control Group
Participants who receive the placebo.
干预措施: Placebos (Drug)
结局指标
主要结局
Body Length
时间窗: 8 to 12 weeks
Body length measured by centimetres
Body Weight
时间窗: 8 to 12 weeks
Body weight measured by gram
Head Circumference
时间窗: 8 to 12 weeks
Head circumference measured by centimetres
次要结局
- Number of participants with intraventricular haemorrhage(8 to 12 weeks)
- Number of participants with bronchopulmonary dysplasia(8 to 12 weeks)
- Number of participants with retinopathy of prematurity(8 to 12 weeks)
- Zinc levels(8 to 12 weeks)
- Rate of mortality(8 to 12 weeks)
- Number of participants with side effects(8 to 12 weeks)
- Number of participants with late-onset sepsis(8 to 12 weeks)
研究者
RismaKK
Principal Investigator
Fakultas Kedokteran Universitas Indonesia