a Randomized Control Trial to Assess the Effect of Early vs Routine Iron Supplementation on Iron Store and Growth in Term Small for Gestational Age and Appropriate for Gestational Age Infants at 1 Year
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Iron deficiency anemia
研究概览
简要总结
Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and 1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored at 6 months and 1 year of age.
详细描述
Study Design: Randomized Controlled Trial, Open label. Study setting: Neonatology unit, Postnatal clinic and children Out Patient Department and growth clinic at Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh Study period: January 2017 to June 2018 Consecutively born all term babies in the labour room, PGIMER,Chandigarh, and residing in tricity area and within 100 km radius of Chandigarh will be screened for fulfilment of inclusion criteria within 1st 24 hours of life. Babies will be classified as SGA or AGA as per Fenton's growth chart.
Details of maternal and neonatal characteristics will be recorded in a structured proforma with a verbal consent of parents and counselling for follow up from 6 weeks onwards till 1 year of age. Details of discharge characteristics and anthropometry will be recorded in a structured format. Exclusive breast feeding till 6 months will be advised to all mothers. Kuppuswamy's scale will be used to assess socioeconomic status.
Birth details of babies will be recorded from the labour room register in PGIMER Labour Room. Their parents will be asked to report to the PostNatal Clinic after 6 weeks for their routine followup. Inclusion and exclusion criteria will be applied at the postnatal visit at 6 weeks, and consent will be taken. Randomisation will be done at 6 weeks in the postnatal clinic, along initiation of iron in the early (6 weeks group) These babies are routinely followed up in Post Natal Clinic (PNC) at 6 weeks for maternal check up and for initiation of vaccination. Subsequently they are seen in Children's OPD at 10 and 14 wks to complete vaccination and at 6 months for complementary feeding advice.
A written, informed consent would be obtained from one of the parents after explaining details of intervention at enrolment at 6 weeks.
Currenly as per unit protocol, all term babies receive only Vitamin D drops 400 IU daily for 1 year. No other supplements are given till 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants (born after 37 completed weeks of gestation by USG dating or LMP and postnatally by New ballard scoring whichever applicable)
- •Appropriate for gestational age (as per revised Fenton's chart 2013)
- •Small for gestational age (birth weight <10th percentile as per revised Fenton's chart 2013) - Parents consenting to follow up till 1 year
- •Parents residing within 100 kilometres of Chandigarh
排除标准
- •H/o blood product transfusion prior to study enrolment
- •Neonatal jaundice due to hemolytic anemia
- •Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without moderate to severe HIE (Hypoxic Ischemic Encephalopathy).
- •Severe sepsis with septic shock
- •Suspect haematological disorders
- •Infants with chronic diseases like congenital heart disease, cholestatic jaundice and suspected liver disease, suspected or diagnosed renal tubular acidosis, suspected or diagnosed inborn errors of metabolism
- •Suspected or proven chromosomal abnormalities.
研究组 & 干预措施
AGA 6 weeks
Iron supplementation will be started at 2mg/kg from 6 weeks of age to 1 year
干预措施: Iron Supplement (Drug)
AGA 6 months
Iron supplementation will be started from 6 months of age to 1 year
干预措施: Iron Supplement (Drug)
SGA 6 weeks
Iron supplementation will be started from 6 weeks of age to 1 year
干预措施: Iron Supplement (Drug)
SGA 6 months
Iron supplementation will be started from 6 months of age to 1 year
干预措施: Iron Supplement (Drug)
结局指标
主要结局
Iron deficiency anemia
时间窗: 1 year
Hemoglobin
次要结局
- Growth parameter2(6 months)
- Growth parameter1(6 months)
- Growth parameter3(6 months)
- Growth parameter4(1 year)
- Iron stores(1 year)
- Growth parameter6(1 year)
- Growth parameter5(1 year)
研究者
Deepanjan Bhattacharya
PRINCIPAL INVESTIGATOR Junior resident
Post Graduate Institute of Medical Education and Research, Chandigarh