BreastfeedingPUMMPPNCT06673160
Pumping to Up Maternal Milk Production for Preterms
A study testing Pumping every 2 hours and breast pumping every 3 hours in people with Breastfeeding and Breastmilk Expression, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Breastfeeding, Breastmilk Expression
- What is being tested?
- Pumping every 2 hours and breast pumping every 3 hours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35249
Colm Travers, MD, 205-934-4680, cptravers@uabmc.edu
Folasade Aderibigbe, MD, 205-934-4680, fmaderibigbe@uabmc.edu
About this study
Official title: Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
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.
- Conditions
- Breastfeeding, Breastmilk Expression
- Being tested
- Pumping every 2 hours, breast pumping every 3 hours
- Keywords
- breastmilk supply in preterm infant, breastfeeding preterm infants
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumping every 2 hoursBehavioural
Also called breast pumping every 2 hours
The intervention will be pumping every 2 hours.
breast pumping every 3 hoursBehavioural
The intervention will be pumping every 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Pumping every 2 hours | Experimental | Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours. Receives: Behavioral: Pumping 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. Receives: Behavioral: breast pumping every 3 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 28 days of life
Secondary outcomes (12)
The percentage of donor breast milk feedings
This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk.
Measured: From enrollment to 28 days of life
The number of days alive on full feedings
The total number of days the infant received full enteral feeds (≥120 milliliters(mL)/kilogram(kg)/day).
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrollment to hospital discharge
Average change in weight
Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age
Measured: from birth to 36 weeks' corrected gestational age
Average change in length
Changes in length measured in centimeters (cm)
Measured: from birth to 36 weeks corrected gestational age
Average change in head circumference
Change in head circumference measured in centimeters (cm)
Measured: 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.
Measured: 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.
Measured: From 18-26 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start11 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673160
- Sponsor's protocol ID
- IRB-300013718
- Other IDs
- UAB
- Acronym
- PUMMPP
- Status last verified
- Jul 2026
- First submitted
- 23 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32520359Santoli 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.
PubMed 37967869Quintero 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.
PubMed 36932332Huang 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.
PubMed 34382733Meek 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
- ClinicalTrials.gov ID
- NCT06673160
- Acronym / sponsor ID
- PUMMPP / IRB-300013718
- Conditions
- Breastfeeding, Breastmilk Expression
- Keywords
- breastmilk supply in preterm infant, breastfeeding preterm infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumping every 2 hours | Experimental | Behavioral: Pumping every 2 hoursMothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours. |
| Pumping every 3 hours | Active comparator | Behavioral: breast pumping every 3 hoursMothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Pumping every 2 hoursAlso: breast pumping every 2 hoursThe intervention will be pumping every 2 hours. | Behavioural | Pumping every 2 hours |
| breast pumping every 3 hoursThe intervention will be pumping every 3 hours | Behavioural | Pumping every 3 hours |
Primary outcome
Volume of expressed breastmilk
Time frame: From enrollment to 28 days of life
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
12 secondary outcomes
The percentage of donor breast milk feedings
Time frame: From enrollment to 28 days of life
The number of days alive on full feedings
Time frame: From enrollment to 28 days of life
The time to full feedings
Time frame: From enrollment to 28 days of life
The number of infants with clinical evidence of feeding intolerance
Time frame: From enrollment to first 28 days after birth
Number of central line days
Time frame: In the first 28 days of life
The number of infants receiving any volume of breastmilk at time of discharge
Time frame: From enrollment to hospital discharge
The number of infants exclusively feeding breastmilk at discharge
Time frame: From enrollment to hospital discharge
Average change in weight
Time frame: from birth to 36 weeks' corrected gestational age
Average change in length
Time frame: from birth to 36 weeks corrected gestational age
Average change in head circumference
Time frame: from birth to 36 weeks' corrected gestational age
The Bayley Scales of Infant and Toddler Development (BSID)
Time frame: from 18-26 months of age
The Bayley Scales of Infant and Toddler Development (BSID)
Time frame: From 18-26 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 32520359Travers 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.
- Background: PubMed 37967869Santoli 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.
- Background: PubMed 36932332Quintero 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.
- Background: PubMed 34382733Huang 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.
- BackgroundMeek 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.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumping every 2 hours and breast pumping every 3 hours in people with Breastfeeding and Breastmilk Expression, run by University of Alabama at Birmingham at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colm Travers, MD (205-934-8793, cptravers@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of expressed breastmilk (time frame: From enrollment to 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06673160, which also lists 5 linked publications.
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 16 Jul 2026.