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临床试验/NCT00643253
NCT00643253已完成3 期

Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Albert Einstein College of Medicine2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
299
试验地点
2
主要终点
Breastfeeding intensity at 1,3, and 6 months

研究概览

简要总结

We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.

The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.

Primary Outcomes (Hypotheses): Breastfeeding

  1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
  2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.

Secondary Outcomes (Hypotheses): Infant Growth 3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits. 4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age. 5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits 6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 12-30 weeks pregnant
  • receives prenatal care at Centennial women's center of Montefiore Medical Center
  • English or Spanish speaking

排除标准

  • pregnant with multiples
  • breastfeeding contra-indicated

研究组 & 干预措施

2

No Intervention

Standard of Care

1

Experimental

Receipt of behavioral interventions to encourage breastfeeding.

干预措施: LC and Electronic Prompt (Behavioral)

结局指标

主要结局

Breastfeeding intensity at 1,3, and 6 months

时间窗: 1,3, and 6 months after birth of the baby

次要结局

  • Infant growth by treatment group and breastfeeding intensity(Assessed when baby is 1,3, and 6 months of age)

研究者

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

Karen Bonuck

Professor

Albert Einstein College of Medicine

研究点 (2)

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