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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is:
- What effect does pumping frequency have on breast milk supply.
Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce.
Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pumping every 2 hours | Experimental | Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours. |
|
| Pumping every 3 hours | Active Comparator | Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumping every 2 hours | Behavioral | The intervention will be pumping every 2 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of expressed breastmilk | The primary outcome measure will be the volume of expressed breastmilk obtained in mL per day in the group pumping every 2 hours compared the group pumping every 3 hours | From enrollment to 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of donor breast milk feedings | This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk. | From enrollment to 28 days of life |
| The number of days alive on full feedings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colm Travers, MD | Contact | 205-934-8793 | cptravers@uabmc.edu | |
| Folasade Aderibigbe, MD | Contact | 205-934-8793 | Sade.Aderibigbe72@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Recruiting | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32520359 | Background | Travers CP, Carlo WA, McDonald SA, Das A, Ambalavanan N, Bell EF, Sanchez PJ, Stoll BJ, Wyckoff MH, Laptook AR, Van Meurs KP, Goldberg RN, D'Angio CT, Shankaran S, DeMauro SB, Walsh MC, Peralta-Carcelen M, Collins MV, Ball MB, Hale EC, Newman NS, Profit J, Gould JB, Lorch SA, Bann CM, Bidegain M, Higgins RD; Generic Database and Follow-up Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Racial/Ethnic Disparities Among Extremely Preterm Infants in the United States From 2002 to 2016. JAMA Netw Open. 2020 Jun 1;3(6):e206757. doi: 10.1001/jamanetworkopen.2020.6757. | |
| 37967869 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| breast pumping every 3 hours | Behavioral | The intervention will be pumping every 3 hours |
|
The total number of days the infant received full enteral feeds (≥120 milliliters(mL)/kilogram(kg)/day).
| From enrollment to 28 days of life |
| The time to full feedings | The number of days it takes to initially reach full enteral feeds (≥120mL/kg/day) | From enrollment to 28 days of life |
| The number of infants with clinical evidence of feeding intolerance | Infants that have enteral feeds withheld, or in other words made "nothing by mouth" (NPO) > 24 hours for feeding or abdominal issues | From enrollment to first 28 days after birth |
| Number of central line days | The total number of days the infant maintained any type of central line access. | In the first 28 days of life |
| The number of infants receiving any volume of breastmilk at time of discharge | Infants who are still receiving any volume of expressed breastmilk upon discharge will be identified and noted. | From enrollment to hospital discharge |
| The number of infants exclusively feeding breastmilk at discharge | Whether or not enrolled infants are receiving all their nutrition from their mom's own expressed breastmilk upon discharge will be noted | From enrollment to hospital discharge |
| Average change in weight | Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age | from birth to 36 weeks' corrected gestational age |
| Average change in length | Changes in length measured in centimeters (cm) | from birth to 36 weeks corrected gestational age |
| Average change in head circumference | Change in head circumference measured in centimeters (cm) | from birth to 36 weeks' corrected gestational age |
| The Bayley Scales of Infant and Toddler Development (BSID) | The Bayley's cognitive component composite score will be assessed and noted. The cognitive composite score is determined by comparing the child's performance to a normative age-matched sample defined by the assessment. They are interpreted as follows: Mean score of 100 (Standard deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Monitoring is recommended, along with advice to parents on techniques to enhance development or referral to a therapist based on the level of impairment. Score below 70 (2 Standard deviation below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay. | from 18-26 months of age |
| The Bayley Scales of Infant and Toddler Development (BSID) | The Bayley's motor component composite score will be assessed and noted. The motor composite score is determined by comparing the child's performance to a normative age-matched sample defined by the assessment. They are interpreted as follows: Mean score of 100 (Standard deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Monitoring is recommended, along with advice to parents on techniques to enhance development or referral to a therapist based on the level of impairment. Score below 70 (2 Standard deviation below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay. | From 18-26 months of age |
| Background |
| Santoli CMA, Taylor-Cho IA, Darling AJ, Montoya MN, Gilner JB, Wheeler SM, Dotters-Katz SK. Predictors of Breastfeeding among Patients Admitted with Preterm Prelabor Rupture of Membranes. Am J Perinatol. 2024 May;41(S 01):e3196-e3201. doi: 10.1055/a-2211-1787. Epub 2023 Nov 15. |
| 36932332 | Background | Quintero SM, Strassle PD, Londono Tobon A, Ponce S, Alhomsi A, Maldonado AI, Ko JS, Wilkerson MJ, Napoles AM. Race/ethnicity-specific associations between breastfeeding information source and breastfeeding rates among U.S. women. BMC Public Health. 2023 Mar 17;23(1):520. doi: 10.1186/s12889-023-15447-8. |
| 34382733 | Background | Huang Y, Liu Y, Yu XY, Zeng TY. The rates and factors of perceived insufficient milk supply: A systematic review. Matern Child Nutr. 2022 Jan;18(1):e13255. doi: 10.1111/mcn.13255. Epub 2021 Aug 12. |
| Background | Meek JY, Tippins S, American Academy of Pediatrics. American Academy of Pediatrics new mother's guide to breastfeeding. New York: Bantam Books; 2002. xiv, 258 p. p. |