Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,908
- 试验地点
- 1
- 主要终点
- Percentage of Mothers with Postpartum Depression (PPD)
研究概览
简要总结
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:
- Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?
- Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?
- What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?
- What is the prevalence of paternal depression in a low resource setting?
- Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge?
Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings.
Participants (infants) will:
- At time of discharge from the NICU, when clinically stable, spend either < 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.
- Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.
- Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.
详细描述
The overarching objective is to determine whether initiation of Kangaroo Mother Care (KMC) at the neonatal intensive care unit (NICU) followed by admission to the KMC ward for continued support for more than 2 days before discharge home reduces maternal postpartum depression (PPD) and other maternal and infant adverse outcomes in low-resource settings. The central hypothesis is that NICU KMC plus admission of mother-infant (preterm) dyads to the KMC ward following NICU discharge for more than 2 days will reduce the risk of maternal PPD as compared to NICU KMC followed by admission of the mother-infant dyad to the KMC ward for up to 2 days only.
The study aims are:
Aim 1: To determine the effect of admission of mother-infant dyads to the KMC Ward following NICU for more than 2 days on maternal PPD at 2 weeks, 6-8 weeks, 6 months, and 12 months.
Aim 2: To determine the effect of admission of mother-infant dyads to the KMC Ward for more than 2 days on infants' developmental outcomes at 6-,12-, and 18 months of age.
Aim 3: To characterize the feasibility and barriers to uptake of KMC at the hospital and following discharge from the perspective of parents and other family members.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIM #1-2 and #5
- •Mothers to newborns who are:
- •1) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months
- •Parents (mothers and fathers) whose newborn has been enrolled in the study
- •Trusted family member or friend of the mother whose newborns is enrolled into the study
- •16+ years of age (mothers and fathers)
- •18+ years of age (family members)
- •Fathers whose newborn has been enrolled into the study
- •16+ years of age (father)
排除标准
- •AIM #1-2 and #5
- •Mothers who are on treatment for depression and/or anxiety
- •Mothers who did not consent
- •Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
- •1) Family members of parents who do not consent to study participation
- •Fathers who are on treatment for depression and/or anxiety
- •Fathers who did not provide informed consent
- •Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
研究组 & 干预措施
Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICU
Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for less than 2 days for continued support.
干预措施: Kangaroo mother care (KMC) support for < 2 days (Behavioral)
Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICU
Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for greater than 2 days for continued support.
干预措施: Kangaroo mother care (KMC) support for > 2 days (Behavioral)
结局指标
主要结局
Percentage of Mothers with Postpartum Depression (PPD)
时间窗: 8 weeks
Score on Edinburgh Postnatal Depression Scale (EPDS) screening tool obtained by interview with mother. This screening tool is a 10-question tool validated for use among pregnant women in low resource countries. It can be used for screening of perinatal depression, beginning from antenatal period up to 6-8 weeks postnatal age. Each question is scored between 0-3, the highest cumulative score being 30. Cut-off score for mothers with suspected postpartum depression (PPD) will be 11. All mothers who screen 11+ will be categorized to have PPD, all mothers scoring below 11 will be categorized as negative for PPD.
次要结局
- Percentage of Mothers with Postpartum Depression (PPD)(2 weeks, 6 months, 12 months)
- Hours spent practicing Kangaroo Mother Care (KMC) in the neonatal intensive care unit (NICU)(2 weeks)
- Hours spent practicing Kangaroo Mother Care (KMC) at home(2 weeks, 8 weeks, 6 months, 12 months)
- Number of barriers to kangaroo mother care (KMC) initiation at the birth hospital(12 months)
- Number of barriers to kangaroo mother care (KMC) initiation at home(12 months)
- Average length in centimeters (cm)(birth, up to 8 weeks, 6 months, 12 months, 18 months)
- Number of facilitators to practicing kangaroo mother care (KMC) at home(12 months)
- Percentage of fathers with postpartum depression(2 weeks, 8 weeks, 6 months, 12 months)
- Percentage of mothers with self-reported perceived social support(6 months, 12 months)
- Cost of readmission to the neonatal intensive care unit (NICU)(Through NICU discharge of up to 8 weeks)
- Percentage of neonatal morbidity(28 days)
- Hours spent practicing Kangaroo Mother Care (KMC) in the KMC Ward(2 weeks)
- Number of months breastfeeding(8 weeks, 6 months, 12 months)
- Average weight in grams(birth, up to 8 weeks, 6 months, 12 months, 18 months)
- Number of barriers to practicing kangaroo mother care (KMC() at the hospital(12 months)
- Time of initiation of breastfeeding(2 weeks)
- Average Infant/child developmental assessment(6 months,12 months, 18 months)
- Average head Circumference in centimeters (cm)(birth, up to 8 weeks, 6 months, 12 months, 18 months)
- Percentage of all cause 28-day neonatal mortality(28 days)
- Percentage of infant readmission to facility(18 months)
- Number of facilitators to practicing kangaroo mother care (KMC) at the hospital(12 months)
- Hours of time father spent with newborn daily(8 weeks, 6 months, 12 months)
- Percentage of infant mortality(18 months)
- Percentage of infant morbidity(18 months)
- Percentage of vaccine adherence(12 months)
- Number of barriers to practicing kangaroo mother care (KMC) at home(12 months)
- Cost of admission to kangaroo mother care (KMC) ward(Through KMC discharge of up to 8 weeks)
- Percentage of mothers with depression(2 weeks, 8 weeks, 6 months, and 12 months)
- Cost associated with hospital readmissions(12 months)
- Out-of-pocket family costs associated with hospital readmissions(12 months)
研究者
Albert Manasyan, MD, MPH
Associate Professor
University of Alabama at Birmingham