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Supporting Mothers of Preterm Infants

Primary Purpose

PreTerm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limited Financial Support
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PreTerm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. 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:

  1. under the age of 18 years
  2. not currently covered by Medicaid
  3. unable to speak or understand English or Spanish
  4. not residents of the state of Massachusetts
  5. 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.

Sites / Locations

  • Tufts Medical Center
  • Lowell General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison

Treatment: Limited Financial Support

Arm Description

Participants will be provided with standard information about the benefits of STSC and breastfeeding and will be encouraged to come into the NICU every day for at least 1 hour of STSC. To facilitate increased let down of breast milk, all participants will be provided a hospital grade breast pump free of charge during the stay of their babies in the NICU and assistance will be provided to the mothers in procuring a Medicaid covered breast pump to keep when the baby leaves the NICU. The hospital grade breast pump will be provided to her as soon as she enrolls into the study and will remain with her until her baby is discharged or transferred.

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. The participants selected for the intervention arm will be asked not to discuss the payment with any other study participants (such as the members of any other families they may see at the NICU) or other health care staff at the NICU. Participants will also receive everything that the Comparison group receives.

Outcomes

Primary Outcome Measures

Proportion of days mothers practice STSC
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 Outcome Measures

Exclusive breastfeeding duration
Mean weeks of exclusive breastfeeding duration among enrolled mothers
Change in head circumference
Difference between head circumference z-score at birth and at 3 months post-discharge
General infant development composite score (based on 5 age-appropriate milestones)
Infant development composite score as measured by 5 age-appropriate motor, communication, and socioemotional milestones
Mental/emotional wellbeing of mother
Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression
Mother-infant attachment
Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire
Readmissions
Fraction of infants who were readmitted to the hospital post-discharge
Cost and cost-effectiveness
Total cost of infant's care, including both hospital and out-of-pocket spending
Any breastfeeding at 3mo
Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months
Breastfeeding initiation
Fraction of mothers who ever begin breastfeeding
Duration of NICU stay
Number of days infants stay in the NICU before discharge
Change in weight-for-age z-score
Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo

Full Information

First Posted
November 4, 2016
Last Updated
July 8, 2019
Sponsor
Tufts Medical Center
Collaborators
Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT03013660
Brief Title
Supporting Mothers of Preterm Infants
Official Title
Supporting Mothers of Preterm Infants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreTerm Birth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Participants will be provided with standard information about the benefits of STSC and breastfeeding and will be encouraged to come into the NICU every day for at least 1 hour of STSC. To facilitate increased let down of breast milk, all participants will be provided a hospital grade breast pump free of charge during the stay of their babies in the NICU and assistance will be provided to the mothers in procuring a Medicaid covered breast pump to keep when the baby leaves the NICU. The hospital grade breast pump will be provided to her as soon as she enrolls into the study and will remain with her until her baby is discharged or transferred.
Arm Title
Treatment: Limited Financial Support
Arm Type
Experimental
Arm Description
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. The participants selected for the intervention arm will be asked not to discuss the payment with any other study participants (such as the members of any other families they may see at the NICU) or other health care staff at the NICU. Participants will also receive everything that the Comparison group receives.
Intervention Type
Other
Intervention Name(s)
Limited Financial Support
Intervention Description
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 Outcome Measure Information:
Title
Proportion of days mothers practice STSC
Description
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)
Time Frame
Captured in hospital records during the first 1-3 weeks after enrollment
Secondary Outcome Measure Information:
Title
Exclusive breastfeeding duration
Description
Mean weeks of exclusive breastfeeding duration among enrolled mothers
Time Frame
Self-reported after 3 months
Title
Change in head circumference
Description
Difference between head circumference z-score at birth and at 3 months post-discharge
Time Frame
Head circumference measured at birth (time 0) and after 3 months
Title
General infant development composite score (based on 5 age-appropriate milestones)
Description
Infant development composite score as measured by 5 age-appropriate motor, communication, and socioemotional milestones
Time Frame
Reported by mother at 3 month survey
Title
Mental/emotional wellbeing of mother
Description
Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression
Time Frame
Self-reported after 3 months
Title
Mother-infant attachment
Description
Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire
Time Frame
Self-reported after 3 months
Title
Readmissions
Description
Fraction of infants who were readmitted to the hospital post-discharge
Time Frame
Self-reported after 3 months
Title
Cost and cost-effectiveness
Description
Total cost of infant's care, including both hospital and out-of-pocket spending
Time Frame
Within 3 months of discharge
Title
Any breastfeeding at 3mo
Description
Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months
Time Frame
Self-reported after 3 months
Title
Breastfeeding initiation
Description
Fraction of mothers who ever begin breastfeeding
Time Frame
Captured in hospital records during first 1-3 weeks after enrollment
Title
Duration of NICU stay
Description
Number of days infants stay in the NICU before discharge
Time Frame
Captured in hospital records during the first 1-3 weeks after enrollment
Title
Change in weight-for-age z-score
Description
Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo
Time Frame
Change between measurement at birth (time 0) and after 3 months after discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Supporting Mothers of Preterm Infants

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