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临床试验/NCT00474422
NCT00474422已完成不适用

Hospital-based Paraprofessional Lactation Clinic

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 522 人开始时间: 2003年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
522
试验地点
2
主要终点
Percent of infants breastfed exclusively

研究概览

简要总结

Hypothesis: We hypothesized that providing in-hospital, supervised paraprofessional breastfeeding consultation during the hiatus between hospital discharge and the first postpartum WIC or pediatric visit would increase the rate of exclusive breastfeeding among low income Hispanic women at 1 month postpartum.

详细描述

Methods:

Eligibility: Hispanic mothers who intended to breastfeed and were scheduled for simultaneous discharge with their healthy infants were eligible for enrollment. Women were excluded if factors indicating elevated risk for hyperbilirubinemia were noted in the infant's chart (<37 weeks gestation at birth, < 48 hours of age at discharge, jaundice within 24 hours of birth, Rh incompatibility; cephalohematoma, positive coombs test, family history of disorders of RBC enzyme defects or defects of RBC shape and size, and exclusive breastfeeding in the hospital).

Setting: Subjects were recruited between during the 2004 calendar year at a large metropolitan Hospital in Houston Texas. Ninety percent of mothers delivering at the facility are first generation immigrants, and 85% are monolingual Hispanic. Infants spend > 4 hours in the newborn nursery before being reunited with their mothers. Feeding counselors assist mothers with latch-on at hospital bedside and encourage exclusive breastfeeding. Ninety-seven percent of mothers initiate breastfeeding and all but 2% of them choose to offer "las dos cosas" (both breast and formula) in the hospital. Infants at elevated risk for hyperbilirubinemia are screened for medical and breastfeeding problems at 3-5 days in a Newborn Follow-up Clinic (NBFC). All mothers receive the telephone number of the hospital's breastfeeding clinic and the WIC office with instructions to call for breastfeeding assistance if needed after discharge. For infants at low risk for hyperbilirubinemia, there is a gap of approximately two weeks between hospital discharge and the first well child exam. The first WIC visit also occurs approximately two weeks postpartum.

Intervention: The intervention consisted of scheduling mothers of infants at low risk for hyperbilirubinemia to visit the hospital-based breastfeeding clinic at 3-7 days post partum. An appointment reminder card was included with the discharge papers. At the breastfeeding clinic, mothers received counseling from bilingual, bicultural paraprofessionals under the supervision of an International Board Certified Lactation Consultant / registered nurse. A breastfeeding history, breast and nipple exam, infant oral-motor assessment, infant weight, observation of a breastfeeding episode with evaluation of latch and milk transfer, and discussion of maternal concerns and support system were included in the counseling sessions. The importance of exclusive breastfeeding was reviewed, and plans for attaining exclusivity were discussed if the mother desired to achieve that goal. Information and skills training were provided as indicated for identified deficits, concerns, and breastfeeding problems. Additional visits and / or telephone consultations were provided if deemed necessary by the mother and the clinic staff.

All clinic contact was recorded by staff. Women who missed appointments received a phone call from a clinic counselor. Visits were rescheduled if possible; if not, counseling was provided over the phone. During phone counseling, mothers were screened for breastfeeding problems and concerns regarding adequacy of milk supply. Problem management was discussed where indicated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • intent to breastfeed
  • delivery at target hospital
  • mother and infant scheduled for joint discharge
  • healthy mother and infant

排除标准

  • infant at elevated risk for hyperbilirubinemia:
  • <37 weeks gestation at birth,
  • < 48 hours of age at discharge,
  • jaundice within 24 hours of birth,
  • Rh incompatibility; cephalohematoma,
  • positive coombs test,
  • family history of disorders of RBC enzyme defects or defects of RBC shape and size,
  • exclusive breastfeeding in the hospital

结局指标

主要结局

Percent of infants breastfed exclusively

时间窗: 4 weeks of age

Daily volume of formula supplement received by mixed feeders

时间窗: at 4 weeks of age

次要结局

  • Maternal and Infant utilization of health care services(during 1st month postpartum)
  • Breastfeeding problems experienced(in first month postpartum)
  • Satisfaction with Hospital care(4 weeks postpartum)
  • Percent of infants receiving water, tea, or Agua de Arroz(4 weeks postpartum)

研究者

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

Dennis Bier

Center Director and Professor

Baylor College of Medicine

研究点 (2)

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