Clinical trial NCT06673160: Pumping to Up Maternal Milk Production for Preterms
Official title: Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Breastmilk Expression
Keywords: breastmilk supply in preterm infant
breastfeeding preterm infants
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 70
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Inborn infants \<32 weeks gestation
* Out-born infants transferred to our facility \<48hours of life
* Infants \<1500 grams at birth
* Infants whose parents/ guardians have provided legal consent for study participation

Exclusion Criteria:

* Infants with birthing persons' that are severe/critically ill
* Birthing persons of infants \<18 years old
* Infants with terminal illness or decision to withhold or limit support
* infants with major congenital anomalies, chromosomal disorders, or congenital infections

Primary outcomes:
measure: Volume of expressed breastmilk
timeFrame: From enrollment to 28 days of life
Secondary outcomes:
measure: The percentage of donor breast milk feedings
timeFrame: From enrollment to 28 days of life
measure: The number of days alive on full feedings
timeFrame: From enrollment to 28 days of life
measure: The time to full feedings
timeFrame: From enrollment to 28 days of life
measure: The number of infants with clinical evidence of feeding intolerance
timeFrame: From enrollment to first 28 days after birth
measure: Number of central line days
timeFrame: In the first 28 days of life
measure: The number of infants receiving any volume of breastmilk at time of discharge
timeFrame: From enrollment to hospital discharge
measure: The number of infants exclusively feeding breastmilk at discharge
timeFrame: From enrollment to hospital discharge
measure: Average change in weight
timeFrame: from birth to 36 weeks' corrected gestational age
measure: Average change in length
timeFrame: from birth to 36 weeks corrected gestational age
measure: Average change in head circumference
timeFrame: from birth to 36 weeks' corrected gestational age
measure: The Bayley Scales of Infant and Toddler Development (BSID)
timeFrame: from 18-26 months of age
measure: The Bayley Scales of Infant and Toddler Development (BSID)
timeFrame: From 18-26 months of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.