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临床试验/NCT03602729
NCT03602729Unknown不适用

Comparison of Teaching Interventions to Improve Breastfeeding Among Mothers of Infants In Neonatal Intensive Care Unit of Brookdale Hospital Medical Center

Brookdale University Hospital Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Exclusive breast feeding

研究概览

简要总结

Investigators plan to include mother-infant couplets admitted to Neonatal Intensive Care Unit(NICU) at Brookdale Hospital for clinical reasons during one year period 1/2018-1/2019. Participants whose infants have health conditions that will not allow breastfeeding, not able to read or understand English and/or participants refusing to provide phone numbers, an email address or mail address for future communication will not be included in the study.

After obtaining an informed consent, participants will be allocated to one of the four study groups by randomization and participants will receive either no education or one of the verbal/written/video education at two different time points: within 4 days and at 2 weeks from the time of birth of the infant. Participants whose infants are in NICU and are feeding expressed breastmilk will be instructed to bring all the expressed breastmilk to NICU and to keep records of the date, time and the amount of expressed breastmilk in the log book maintained at the bedside of the infant. Participants who are directly feeding the infant on breast will be contacted by third personnel who is blind to which study group the participant belongs to qualitatively evaluate breast feeding in terms of frequency, duration, exclusive breast feeding at 2 weeks, 4 weeks and 6 weeks from the time of birth. Participants will be requested not to reveal the study team about the mode of teaching method she has received when she is contacted at 2 weeks, 4 weeks and 6 weeks for the evaluation of the breast feeding. Investigators will also go through the medical records of participants and their infants to collect some demographic data and clinical characteristics pertinent for the study such as age, parity, weight of the infant.

Thus, investigators plan to compare the breast-feeding outcome quantitatively among participants who are feeding expressed breast milk and qualitatively as duration/exclusive breast-feeding among participants who are feeding directly on breast following three different teaching interventions: written or verbal or video and find out the most effective method of teaching intervention

详细描述

The purpose of the study is to compare the breast-feeding outcome following three different teaching interventions: written or verbal/direct or visual/videos among participants whose infants are admitted in Neonatal Intensive Care Unit (NICU) at Brookdale Hospital

  1. Breast-feeding outcome among participants who are feeding expressed breast milk will be measured quantitatively as amount of milk production per day on an average during NICU stay.
  2. Breast-feeding outcome among participants who are directly feeding the infants at breast will be measured qualitatively in terms of frequency, duration, exclusive breast feeding at 2 weeks, 4 weeks and 6 weeks of infant's life.

CLINICAL SIGNIFICANCE Investigators are including participants whose infants are admitted to the Brookdale NICU This also include very preterm [<32 weeks] infants, the period when breastfeeding incidence has been lesser compared to participants who give birth at later gestation and those who don't require admission to NICU. By including participants who give birth <32 weeks and newborns admitted to NICU, investigators will be able to document the quantity of breast milk production by logging the milk brought to our NICU storage freezer by participants and effectively measure the outcome objectively of the three different interventions [written, verbal and visual methods].

Previous studies have found that breast feeding is lower among African American population. Since most of population at Brookdale hospital is African American, this study will also give an opportunity to find the result of education intervention among this population Investigators propose that this study will be useful to find the most effective mode to educate participants whose neonates admitted to NICU about breast-feeding and may enhance the culture of breastmilk feeding in this population and therefore increase breast feeding among newborns admitted to the NICU.

METHODOLOGY This is a prospective randomized study on breast-feeding teaching intervention on participants who give birth to newborns that are admitted to NICU at Brookdale Hospital during one-year period 1/2018-1/2019.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Mother-infant couplets with newborns admitted to NICU at Brookdale Hospital for clinical reasons.

排除标准

  • Any contraindications to breast-feeding such as galactosemia, protein milk allergy, HIV infection, maternal substance abuse
  • Mothers not able to read and/or understand English
  • Mothers refusing to provide phone number or an email address or mail address for future communication

研究组 & 干预措施

Group 2

Experimental

Written BF education

干预措施: Breastfeeding education (Other)

Group 1

No Intervention

No study related education given

Group 3

Experimental

Verbal BF education

干预措施: Breastfeeding education (Other)

Group 4

Experimental

Video BF education

干预措施: Breastfeeding education (Other)

结局指标

主要结局

Exclusive breast feeding

时间窗: 6 weeks

Exclusive breast feeding as yes or no

amount of breast milk expression

时间窗: 6 weeks

amount of breast milk expression in milliliters

Duration of breast feeding

时间窗: 6 weeks

Duration of breast feeding in weeks

Frequency of breast feeding

时间窗: 6 weeks

Frequency of breast feeding in number of times in a day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Surichhya Bajracharya

Resident in pediatrics

Brookdale University Hospital Medical Center

研究点 (2)

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