跳至主要内容
临床试验/CTRI/2024/07/071488
CTRI/2024/07/071488尚未招募不适用

Effect of Antenatal Lactation Counselling on Exclusive Breastfeeding in Primigravida Mothers in a Tertiary Care Setup An Open labelled Randomized Control Trial

Not Applicable1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
The initiation time point of breastfeeding and total

研究概览

简要总结

EFFECT OF ANTENATAL LACTATION COUNSELLING ON

EXCLUSIVE BREASTFEEDING IN PRIMIGRAVIDA MOTHERS IN A

TERITARY CARE SETUP :OPEN LABELLED RANDOMIZED

CONTROL TRIAL

Introduction:

Breast milk is the ideal source of nutrition for babies less than 6 months of age. As per WHO

guidelines exclusive breastfeeding should be done till 6months of age and breastfeeding

should be continued in weaning children till 2 years of age. Breast milk has optimum amount

of nutrition (carbohydrate, fat and protein) required for the growth of the infant. Breast milk

is rich in antibodies which helps to protect infants against childhood illnesses. Breast milk

also helps in quick recovery from diseases. Exclusive breastfeeding has the potential to

reduce under 5 mortality rate by 13%. Long term benefits of breastfeeding have also been

established, a systematic review conducted by WHO suggested that breastfeeding helped in

improving IQ and longer duration of breastfeeding played protective role against type 2 DM

and obesity. The promotion and support of breastfeeding is a global priority and important

child survival intervention. Antenatal counselling and postnatal support will help in early

initiation and exclusive breastfeeding and will improve rates of exclusive breastfeeding till 6

months of age.

Aims and Objectives:

Primary:

To assess the impact of antenatal lactation counselling in increasing the initiation and

duration of exclusive breastfeeding.

Secondary :

To compare the rates of illness and hospitalizations in infants who are exclusively breastfed

till 6 months of age versus those who are not exclusively breastfed.

Methodology: With the help of open labelled randomization participants will be divided in two groups. It will be conducted by Department of Pediatrics and Neonatology at AIIMS Patna. This is a single center study.  A total of 200 women who are coming for regular antenatal visits will be included in our study. Based on open labelled randomization using sealed envelope software they will be divided in two groups. Written informed consent will be taken from all participants. Group A: A total of 100 primigravida mothers who are visiting antenatal clinic for

regular antenatal checkup.These women will be given of lactation counselling during their each antenatal visit in Pediatric OPD. Each session will be of 30 minutes each. For each participant in group A , minimum two sessions of counselling will be done. Group B: A total of 100 primigravida women who are visiting antenatal clinic for regular checkup They will receive regular lactation counselling in post natal ward after delivery. Post delivery, all the women will be followed up at our post natal ward, and the following points will be checked:

a) Initiation if breastfeeding within first 30-60 minutes after birth?

b) Frequency of breastfeeding

c) Use of prelacteal feeds

d) Use of pacifiers/ teats

e) Use of formula/animal milk

Both the groups will be followed up at Day 7,6 week ,10 week,14 week and 6 months

at AIIMS PATNA OPD or telephonically and following questions will be asked:

a) If exclusive breast feeding is being continued :

b) Use of formula feed or animal milk :

c) Reason for starting formula feed or animal milk :

d) If the child has suffered from any illness/ hospitalizations :

Implications:

With the help of this study we will be able to understand the barriers mothers face during

breastfeeding and how antenatal lactation counselling will help in promoting breastfeeding.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • A total of 200 women who are coming for regular antenatal visits to AIIMS PATNA will be included in our study.

排除标准

  • Mothers with Cancer breast or on cytotoxic and chemotherapy drugs.
  • Mothers of babies born with oro-pharyngeal abnormalities like cleft lip and palate -Mother of babies requiring NICU admission within 24 hours of birth -Mothers admitted in ICU within 24 hours of delivery.

结局指标

主要结局

The initiation time point of breastfeeding and total

时间窗: Day 1 and Day 7,6 week ,10 week,14 week and 6 months

duration of exclusive breastfeeding.

时间窗: Day 1 and Day 7,6 week ,10 week,14 week and 6 months

次要结局

  • -Use of prelacteal feeds at birth(-Use of pacifiers/ teats)

研究者

申办方类型
Other [No Sponser]
责任方
Principal Investigator
主要研究者

Bhabesh Kant Chowdhary

All India Institute of Medical Sciences Patna

研究点 (1)

Loading locations...

相似试验