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Completed

NCT Number: NCT03013660

Supporting Mothers of Preterm Infants

Preterm birth is the leading contributor to mortality among children younger than 5 years. One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few hours, ideally every day. This intervention can make breastfeeding easier and can improve the health and development of the baby.

Unfortunately, despite the large health benefits, mothers in low-resource communities are often unable to practice STSC due to a range of institutional and economic barriers. STSC requires substantial time and financial commitments from mothers; they must travel from home each day to the hospital to engage in STSC and provide expressed breast milk. Low-income women with access only to limited federally provided unpaid family leave may have to choose between returning to work while their baby is in the NICU and being able to stay at home with their newborn after discharge from the NICU. Families of preterm infants also face direct financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare for older children).

This trial aims to examine the impact of providing additional support to low-income mothers of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the participants will be randomized to receive an additional financial support intervention while their infant is in the NICU. The study will examine how this intervention impacts mothers' health behavior while their child is in the NICU and up to three months after.

Most of the current and past policy efforts to increase STSC have focused on the delivery of STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and informed staff. However, interventions that focus exclusively on hospitals are unlikely to be sufficient for low-income women if there are significant opportunity costs or transportation costs to simply being present at the hospital. This study aims to provide more evidence to determine whether removing these financial barriers has the potential to mitigate the poor outcomes of preterm babies born to lower socioeconomic status households.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mothers who gave (preterm) birth at the study hospitals as well mothers who gave birth elsewhere (e.g. at a hospital without a high-level NICU) but whose babies were immediately transferred to the study hospitals for preterm care after birth.
  • mothers of children born between 30 and 36 weeks of gestation without any major complications requiring additional or special medical care for mother and child

Exclusion criteria

  • under the age of 18 years
  • not currently covered by Medicaid
  • unable to speak or understand English or Spanish
  • not residents of the state of Massachusetts
  • any of the following complications: HIV infection, active tuberculosis, are undergoing radiation therapy, recent breast surgery, indications of illicit drug use currently or during pregnancy (from meconium or cord sample, or urine test), or other contraindications for breastfeeding; or their baby has congenital, surgical, or cardiac anomalies. Note that enrolled women who are identified as using illicit drugs after enrollment will be removed from the study per hospital protocol.

Treatment and study plan

Limited Financial Support

Other

Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment.

Primary outcomes

  1. Proportion of days mothers practice STSC

    Time frame: Captured in hospital records during the first 1-3 weeks after enrollment

    Number of days enrolled mothers practice STSC divided by the total number of days their infant is stable in the NICU (count starts after enrollment)

Secondary outcomes

  1. Exclusive breastfeeding duration

    Time frame: Self-reported after 3 months

    Mean weeks of exclusive breastfeeding duration among enrolled mothers

  2. Change in head circumference

    Time frame: Head circumference measured at birth (time 0) and after 3 months

    Difference between head circumference z-score at birth and at 3 months post-discharge

  3. General infant development composite score (based on 5 age-appropriate milestones)

    Time frame: Reported by mother at 3 month survey

    Infant development composite score as measured by 5 age-appropriate motor, communication, and socioemotional milestones

  4. Mental/emotional wellbeing of mother

    Time frame: Self-reported after 3 months

    Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression

  5. Mother-infant attachment

    Time frame: Self-reported after 3 months

    Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire

  6. Readmissions

    Time frame: Self-reported after 3 months

    Fraction of infants who were readmitted to the hospital post-discharge

  7. Cost and cost-effectiveness

    Time frame: Within 3 months of discharge

    Total cost of infant's care, including both hospital and out-of-pocket spending

  8. Any breastfeeding at 3mo

    Time frame: Self-reported after 3 months

    Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months

  9. Breastfeeding initiation

    Time frame: Captured in hospital records during first 1-3 weeks after enrollment

    Fraction of mothers who ever begin breastfeeding

  10. Duration of NICU stay

    Time frame: Captured in hospital records during the first 1-3 weeks after enrollment

    Number of days infants stay in the NICU before discharge

  11. Change in weight-for-age z-score

    Time frame: Change between measurement at birth (time 0) and after 3 months after discharge

    Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study title

Supporting Mothers of Preterm Infants: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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