PreTerm BirthNCT03013660
Supporting Mothers of Preterm Infants
A study testing Limited Financial Support in people with PreTerm Birth, run by Tufts Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PreTerm Birth
- What is being tested?
- Limited Financial Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2017to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Lowell General Hospital
Lowell, Massachusetts, 01854
About this study
Official title: Supporting Mothers of Preterm Infants: A Randomized Controlled Trial
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).
Read more
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.
- Conditions
- PreTerm Birth
- Being tested
- Limited Financial Support
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited Financial SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison | No intervention | 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. |
| Treatment: Limited Financial Support | Experimental | 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. Receives: Other: Limited Financial Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Captured in hospital records during the first 1-3 weeks after enrollment
Secondary outcomes (11)
Exclusive breastfeeding duration
Mean weeks of exclusive breastfeeding duration among enrolled mothers
Measured: Self-reported after 3 months
Change in head circumference
Difference between head circumference z-score at birth and at 3 months post-discharge
Measured: Head circumference measured at birth (time 0) and after 3 months
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
Measured: Reported by mother at 3 month survey
Mental/emotional wellbeing of mother
Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression
Measured: Self-reported after 3 months
Mother-infant attachment
Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire
Measured: Self-reported after 3 months
Readmissions
Fraction of infants who were readmitted to the hospital post-discharge
Measured: Self-reported after 3 months
Cost and cost-effectiveness
Total cost of infant's care, including both hospital and out-of-pocket spending
Measured: Within 3 months of discharge
Any breastfeeding at 3mo
Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months
Measured: Self-reported after 3 months
Breastfeeding initiation
Fraction of mothers who ever begin breastfeeding
Measured: Captured in hospital records during first 1-3 weeks after enrollment
Duration of NICU stay
Number of days infants stay in the NICU before discharge
Measured: Captured in hospital records during the first 1-3 weeks after enrollment
Change in weight-for-age z-score
Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo
Measured: Change between measurement at birth (time 0) and after 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion5 Jul 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013660
- Sponsor's protocol ID
- IRB15-3993
- Status last verified
- Jul 2019
- First submitted
- 4 Nov 2016
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Mothers of Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03013660
- Acronym / sponsor ID
- IRB15-3993
- Conditions
- PreTerm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Jan 2017
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | No intervention | –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. |
| Treatment: Limited Financial Support | Experimental | Other: Limited Financial SupportSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limited Financial SupportSubjects 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. | Other | Treatment: Limited Financial Support |
Primary outcome
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)
11 secondary outcomes
Exclusive breastfeeding duration
Time frame: Self-reported after 3 months
Change in head circumference
Time frame: Head circumference measured at birth (time 0) and after 3 months
General infant development composite score (based on 5 age-appropriate milestones)
Time frame: Reported by mother at 3 month survey
Mental/emotional wellbeing of mother
Time frame: Self-reported after 3 months
Mother-infant attachment
Time frame: Self-reported after 3 months
Readmissions
Time frame: Self-reported after 3 months
Cost and cost-effectiveness
Time frame: Within 3 months of discharge
Any breastfeeding at 3mo
Time frame: Self-reported after 3 months
Breastfeeding initiation
Time frame: Captured in hospital records during first 1-3 weeks after enrollment
Duration of NICU stay
Time frame: Captured in hospital records during the first 1-3 weeks after enrollment
Change in weight-for-age z-score
Time frame: Change between measurement at birth (time 0) and after 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited Financial Support in people with PreTerm Birth, run by Tufts Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of days mothers practice STSC (time frame: Captured in hospital records during the first 1-3 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.