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临床试验/CTRI/2026/01/101471
CTRI/2026/01/101471尚未招募不适用

manual method vs breast pump for breast milk expression in poorly sucking term babies in first postnatal week

vinayaka missions medical college1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2026年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
432
试验地点
1

研究概览

简要总结

STUDY OBJECTIVE

To compare breast milk volume between manual breast milk expression and breast pump expression among mothers of term infants with poor latch or poor suck at different time points on postnatal day 2 day 3 and day 4

STUDY DESIGN

Randomized controlled trial

STUDY SETTING

Postnatal ward of a tertiary care hospital

INCLUSION CRITERIA

Mothers of term infants equal to or more than 37 weeks gestation

Infants with poor latch or poor suck

Poor latch or poor suck determined by maternal interview review of lactation consultation and assessment by a study doctor or nurse

EXCLUSION CRITERIA

Mother age less than 18 years

History of breast surgery other than cyst removal

Infants with gestational age less than 37 weeks

Birth weight less than 2500 g

RANDOMIZATION

Eligible mother infant less than 7days were randomly assigned to one of two groups

Manual expression group

Pump expression group

INTERVENTIONS

PRE INTERVENTION PROCEDURE

Initial infant weight recorded using the same weighing scale

Mothers attempted breastfeeding with advice and support from a study doctor or nurse

MANUAL EXPRESSION GROUP

Mothers were taught Marmet hand expression technique

Hand expression performed for 15 minutes in a single supervised session

PUMP EXPRESSION GROUP

Mothers were taught breast pumping technique

Bilateral electric breast pump used for 15 minutes in a single supervised session

Vacuum setting started at 30 mm Hg and gradually increased as tolerated

OUTCOME MEASURES

Expressed breast milk volume measured after expression

Cumulative milk volume calculated

All expressed milk measured using a syringe

Expressed milk fed to infants using syringe cup or spoon

Infants reweighed on the same scale after feeding

QUESTIONNAIRES

Breastfeeding confidence assessment

Breastfeeding related pain assessed in breast lower abdomen back and perineum on a scale of 0 to 10

Assessment of social support for milk expression

Assessment of personal and learning experience of milk expression

FOLLOW UP

Phone follow up at 2 weeks 1 month and 2 months

Assessment of breastfeeding milk expression and formula use

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • POOR SUCKING TERM EARLY NEONATE.

排除标准

  • PRETERM MOTHER PREVIOUS BREAST SURGERY.

研究者

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

Giraboina Bhavitha

VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL

研究点 (1)

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