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临床试验/CTRI/2018/04/013096
CTRI/2018/04/013096已完成不适用

Post-Delivery Re-inforcement of Education on Essential newborn care in Malnourished Primigravidae and Assessment of Impact on Growth and Iron Status in Infants till 6 months:A Single Blinded Randomised Controlled Trial

Neha1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年1月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Neha
入组人数
88
试验地点
1
主要终点
Primary outcomes:

研究概览

简要总结

Every year .75 million neonates die in India which is highest in the world.The concept of essential newborn care implies how short and simple interventions can provide both immediate and long term benefits in these babies.

The concept of Essential Newborn Car given by WHO includes:

1)cleanliness of cord and delivery

2)Thermal protection

3)Early and exclusive breastfeeding

4)Initiation of breastfeeding and resuscitation

5)Eye care

6)Immunization

7)Management of newborn illnesses

8)Care of preterms and Low Birth Weight Infants

Study group will be selected upon satisfying both inclusion and exclusion criteria.Study participants will be approached in the ward they are admitted .The nature and objectives of study to be explained to them in a language they comprehend.A written informed consent will be obtained from them.After that a pre-tested questionnaire will be administered to the study participants.Using simple random sampling and block randomization,the study subjects will be divided in intervention group and those receiving standard care.

The intervention group will receive re-inforcement of the ENC knowledge by a trained MSW worker while the standard group will recieve knowledge by existing IEC system.

The outcome will be measured in terms of increase in weight and growth velocity measured at 0,6,10,14 weeks and 6 months.Ferritin levels  will be measured of the mother during the perinatal period and of the baby at birth(cord blood) and at 6 months.

The attempt to assess the knowledge of malnourished mothers will help to identify the lacunae for improvement in the existing system and by re-inforcing the ENC knowledge through flip charts and demonstrations,a better outcome can be obtained in terms of infant growth velocity and weight. Assessment of ferritin levels at birth and at 6 months will help to identify early iron deficiency and subsequent treatment can be given.

Conclusion:

Mothers who were formally trained with flip charts and practice session had better retention of ENC knowledge. The peripartum period was a receptive time for the mother. Educating her to take care of the baby helped in achieving better infant growth. The babies who were exclusively breast fed have lower ferritin, however it was not statistically significant. The growth of the baby was not related to the maternal and foetal iron stores.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Primigravidae mothers Singleton Pregnancy Pre-Pregnancy weight or First Documented Weight less than 45 kg.

排除标准

  • 1.Gravida with life threatening conditions(Pre-eclampsia and eclampsia, uncontrolled blood sugar with HbA1C >6.5%,Uncompensated cardiovascular diseases with NYHA Grade 3 and above) 2.Neonates with gross congenital anomalies 3.Neonates with NICU stay.

结局指标

主要结局

Primary outcomes:

时间窗: 0,6,10,14 weeks and 6 months for the baby. | at birth for mother.

Infant’s weight gain and growth velocity plotted against WHO growth standards.

时间窗: 0,6,10,14 weeks and 6 months for the baby. | at birth for mother.

Status of iron levels in mothers and their newborns.

时间窗: 0,6,10,14 weeks and 6 months for the baby. | at birth for mother.

次要结局

  • Total duration of exclusive breast feeding .(Hygiene practices.)

研究者

发起方
Neha
申办方类型
Other []

研究点 (1)

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