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Late preterm infants (LPT, gestational age 34 0/7 - 36 6/7 weeks) are the largest proportion of all preterm (less than 37 weeks gestation) infants. Recent evidence finds an increased risk of early post-discharge morbidity and re-hospitalization among LPT as compared to full term infants, which is linked to breastfeeding, specifically to early lactation failure and decreased breast milk intake. Accurate and inexpensive methods to collect data on rates of breastfeeding and early morbidity among LPT infants are critical to design, implementation and monitoring of effective interventions. This pilot study evaluates the feasibility of weekly phone calling in a racially and socioeconomically diverse population of mothers of LPT infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phone calling | Other | Weekly telephone call. There are not two arms to the study. The primary intervention is phone calling weekly to assess ability to complete phone call and obtain feeding data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly telephone call | Procedure | Details of feeding and health/sickness will be obtained |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phone Call Completion Rate | Phone call Completion is defined as the phone call was answered by the participant and information was obtained on the survey measures. Phone call completion rate is the number of calls completed over the study period. | Time frame: 13 weeks (3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia M Furman, M.D. | Case Western Reserve University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
One infant was withdrawn from the study due to an unexpectedly long hospital stay (>13 weeks), yielding a total of 38 study infants.
Of 84 inborn LPT infants admitted, 68 (81%) were eligible of whom 39 (57%) agreed to participate, 27 declined and 2 were missed due to brief hospital stays. Sixteen were ineligible: teen mother (7), major congenital malformation (3), positive maternal toxicology screen (2), custody uncertain/other reason (4).
| ID | Title | Description |
|---|---|---|
| FG000 | Phone Calling | Weekly telephone call. There are not two arms to the study. The primary intervention was phone calling weekly to assess ability to complete phone call and obtain feeding data. Weekly telephone call: Details of feeding and health/sickness were obtained |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phone Calling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | mean age of 26.8 years (SD = 6.1) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phone Call Completion Rate | Phone call Completion is defined as the phone call was answered by the participant and information was obtained on the survey measures. Phone call completion rate is the number of calls completed over the study period. | Posted | Number | calls | Time frame: 13 weeks (3 months) | phone call | phone call |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phone Calling | Weekly telephone call. There are not two arms to the study. The primary intervention is phone calling weekly to assess ability to complete phone call and obtain feeding data. Weekly telephone call: Details of feeding and health/sickness will be obtained |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| loss of confidentiality | General disorders | Systematic Assessment | The primary adverse event for this study would be loss of confidentiality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lydia Furman | UHClevelandMC | 216-844-8260 | Lydia.Furman@uhhospitals.org |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| phone call |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
|
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