跳至主要内容
临床试验/CTRI/2024/05/066920
CTRI/2024/05/066920尚未招募不适用

Improving exclusive breastfeeding through effective interventional counselling in an immunisation clinic in a tertiary hospital

Kasturba Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
试验地点
1
主要终点
a)comparative difference in rates of exclusive breast feeding between two groups

研究概览

简要总结

The study will be conducted in the Department of Neonatology and Pediatrics, Kasturba Hospital, Manipal, India. All mother-infant pairs who visit the immunization clinic at 6-8 weeks of age will be screened for eligibility. After obtaining written informed consent, those who fulfil the inclusion criteria will be included in the study. Demographic details like antenatal, birth history, feeding history, type of feeding (direct breastfeeding, expressed breastmilk, formula, or combined), and problems faced with feeding (maternal and infant related) will be noted. Breastfeeding habits will be assessed with a standard questionnaire. The mother-infant pair fulfilling the inclusion criteria will be counselled with standard counselling (Cohort 1) for the first three months of the study. In the next three months, they will be counselled using educational interventional counselling (Cohort 2). Infants in cohort 1 will receive regular standard verbal counselling per hospital protocol. Infants in cohort 2 will receive a standard educational interventional counselling session, including breastfeeding videos, brochures, pamphlets, etc. (all resources attached in a separate document titled- RESOURCES). Infants in both cohorts will be followed up in the immunization clinic at six months of age. Those who could not visit at six months of age will be contacted over the telephone. Data on breastfeeding practices, infections ( diagnosis and treatment/ recurrence of any diarrhoea, cough, Acute Respiratory Infections, pneumonia, meningitis, etc., at a clinic or hospital),  noncompliance, and problems mothers face in feeding or discontinuing exclusive breastfeeding before six months of age will be documented via a proforma. After validation, a standard breastfeeding assessment questionnaire will be prepared from pre-existing formats and applied to all Mother-Infant pairs. This questionnaire will assess feeding habits, barriers to feeding, and well-being of mother-infant pairs.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Day(s) 至 7.00 Month(s)(—)
性别
All

入选标准

  • The study groups consist of clinically stable mother-infant pair seen at the immunization clinic at 6-8 weeks of age.

排除标准

  • Infants who were born preterm Congenital anomalies Chromosomal anomalies Surgical conditions, if any Not given consent.

结局指标

主要结局

a)comparative difference in rates of exclusive breast feeding between two groups

时间窗: Assessed at the end of the 6 month follow up of both cohorts

次要结局

  • b) comparative difference in rates of infection (ARI and ADD) between two groups
  • c) Barriers to exclusive breastfeeding(6 months of age)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sudiksha Gupta

Kasturba Medical College and Hospital

研究点 (1)

Loading locations...

相似试验