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临床试验/CTRI/2025/11/097598
CTRI/2025/11/097598尚未招募不适用

Assessment of Breastfeeding Difficulties at 6-12 hours of delivery and at discharge using the LATCH SCORE: A Prospective Observational Study

Abhilasha Singh1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Percentage of mother-infant dyads having low LATCH score at 6-12 hours of birth and at discharge

研究概览

简要总结

Informed consent will be taken from the enrolled mother-infant dyads meeting the inclusion criteria. Demographic details of the recruited mothers will be recorded.The study is designed as a prospective observational study which will be conducted in the postnatal ward of ESIC, Hospital and PGIMSR, Basaidarapur. A total of 180 mothers will be enrolled in the study. Data collection will be done using a pre-designed proforma. Initial data will be collected within the first 6-12 hrs of observing a breastfeeding session using the LATCH Score. Breastfeeding counselling will be done daily till discharge. Again the LATCH Score will be calculated at the time of discharge. The participants will be followed up at 6 weeks of age through an in-person visit at the well-baby clinic. Breast feeding status will be assessed and weight of the baby will be recored. The LATCH Score comprises of five components. The five components are as follows, LATCH, AUDIBLE SWALLOWING, TYPE OF NIPPLE, COMFORT During breastfeeding and HOLD. A LATCH Score between 8-10 is considered good, 4-7 is considered moderate and less than 4 is considered poor. The data will be entered into the MS Excel spreadsheet and analysis will be done using the software SPSS Version 25. Categorical variables will be presented in frequency and percentage and continuous variables will be presented as mean plus/minus Standard Deviation and median. The quantitative variables will be compared using t-test and Mann Whitney U test. Qualitative variables will be compared by chi-square testing. For testing significance P-value of less than 0.05 will be considered statistically significant.

研究设计

研究类型
Observational

入排标准

年龄范围
9.25 Month(s) 至 10.50 Month(s)(—)
性别
All

入选标准

  • All postnatal mothers having neonates from the gestation 37 weeks and above Singleton live births.

排除标准

  • Mothers with severe postpartum complications Newborns admitted to NICU Newborns with congenital anomalies affecting breastfeeding like cleft lip,cleft palate Mothers with contraindications for breastfeeding.

结局指标

主要结局

Percentage of mother-infant dyads having low LATCH score at 6-12 hours of birth and at discharge

时间窗: Percentage of mother-infant dyads having low LATCH score at 6-12 hours of birth and at discharge

次要结局

  • Association between LATCH score at discharge with exclusive breastfeeding rate & weight at 6 weeks of age(weight assessment at 6 weeks of life)

研究者

发起方
Abhilasha Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Abhilasha Singh

ESIC model Hospital and PGIMSR, Basaidarapur

研究点 (1)

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