Human Milk/BreastfeedingNCT07268105
Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
A study testing The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. in people with Human Milk/Breastfeeding and Breast Pumping, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Milk/Breastfeeding, Breast Pumping
- What is being tested?
- The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 2 Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have newborn in NICU
- Using a breast pump Ability to pump 6-8 times a day
Who cannot join
- Not using a breast pump No newborn in the NICU
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents. Flanges are the part of the pump that fits over the breast and through suction, pulls on the nipple to extract the milk. Recent research showed that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies.
We hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
We are conducting a randomized control trial to explore whether the Flange FITS process is better than the standard (manufacturers instructions) for breastpump flange fitting for new parents who are pumping their milk for their newborns in the NICU. We will randomize (1:1) participants to either the new type of flange fitting (Flange FITS) or usual standard care. The study team will assist the pumping parent participant with flange fitting according to their group. This study will ask the pumping parent participants for information about their child and their experience with pumping, and requests that they record the weight of their breast milk after each pump while in the study. The participants already have the pumps and flanges as part of their standard of care. The researchers will provide participants with a scale to weight their breastmilk after each pump while int he study. The researchers will not go into the medical record to retrieve information for the purposes of the study; all information collected for the study will come from the pumping parent participant.
Read the detailed description
Recent research shows that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies. https://www.babiesincommon.com/flange-fits-guide Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents.
In this study we will 1:1 randomize lactating people with neonates in the NICU to the experimental group (Flange FITS Guide sizing method) or the control group (flange manufacturers sizing guide).
The investigators hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
Aims:
- Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.
- Determine in there is an increase in comfort with breastfeeding, breastfeeding satisfaction, length of pumping with the use of the Flange FITS TM Guide sizing method.
- Conditions
- Human Milk/Breastfeeding, Breast Pumping
- Being tested
- The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
- Keywords
- breast pump, human milk
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.Other
The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
| Study group | Role | What they receive |
|---|---|---|
| Control/usual care | Active comparator | Pumping people will be provided the usual education and flange fitting procedures. Receives: Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. |
| Intervention group | Experimental | This groups will receive the FLANGEFITS protocol. Receives: Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of milk
The weight of the milk will be collected. A food grade scale will be used.
Measured: Maximum participation is 3 weeks
Secondary outcomes (1)
Pumping satisfaction
Satisfaction with use of the pump will be collected with a validated measure.
Measured: Maximum participation in 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Mar 2026
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Why it stopped: This study does not need to be in CLinicalTrials.gov
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 Human Milk/BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is the type of fitting provided for using the pump. Usual fitting versus the FLANGEFITs protocol.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268105
- Sponsor's protocol ID
- HP-00114021
- Other IDs
- HP-00114021
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small internal grant. We also need to protect the privacy of participants. We plan to publish results.
Publications
Purdy IB, Singh N, Le C, Bell C, Whiteside C, Collins M. Biophysiologic and social stress relationships with breast milk feeding pre- and post-discharge from the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):347-57. doi: 10.1111/j.1552-6909.2012.01368.x.
PubMed 22834882Alves E, Rodrigues C, Fraga S, Barros H, Silva S. Parents' views on factors that help or hinder breast milk supply in neonatal care units: systematic review. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F511-7. doi: 10.1136/archdischild-2013-304029. Epub 2013 Jul 18.
PubMed 23867708Anders LA, Robinson K, Ohlendorf JM, Hanson L. Unseen, unheard: a qualitative analysis of women's experiences of exclusively expressing breast milk. BMC Pregnancy Childbirth. 2022 Jan 21;22(1):58. doi: 10.1186/s12884-022-04388-6.
PubMed 35062895Meek JY, Noble L; Section on Breastfeeding. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics. 2022 Jul 1;150(1):e2022057988. doi: 10.1542/peds.2022-057988.
PubMed 35921640Lau CYK, Lok KYW, Tarrant M. Breastfeeding Duration and the Theory of Planned Behavior and Breastfeeding Self-Efficacy Framework: A Systematic Review of Observational Studies. Matern Child Health J. 2018 Mar;22(3):327-342. doi: 10.1007/s10995-018-2453-x.
PubMed 29427014
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
- ClinicalTrials.gov ID
- NCT07268105
- Acronym / sponsor ID
- HP-00114021
- Conditions
- Human Milk/Breastfeeding, Breast Pumping
- Keywords
- breast pump, human milk
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study does not need to be in CLinicalTrials.gov
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 5 Dec 2025 (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.
Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents. Flanges are the part of the pump that fits over the breast and through suction, pulls on the nipple to extract the milk. Recent research showed that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies.
We hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
We are conducting a randomized control trial to explore whether the Flange FITS process is better than the standard (manufacturers instructions) for breastpump flange fitting for new parents who are pumping their milk for their newborns in the NICU. We will randomize (1:1) participants to either the new type of flange fitting (Flange FITS) or usual standard care. The study team will assist the pumping parent participant with flange fitting according to their group. This study will ask the pumping parent participants for information about their child and their experience with pumping, and requests that they record the weight of their breast milk after each pump while in the study. The participants already have the pumps and flanges as part of their standard of care. The researchers will provide participants with a scale to weight their breastmilk after each pump while int he study. The researchers will not go into the medical record to retrieve information for the purposes of the study; all information collected for the study will come from the pumping parent participant.
Detailed description
Recent research shows that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies. https://www.babiesincommon.com/flange-fits-guide Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents.
In this study we will 1:1 randomize lactating people with neonates in the NICU to the experimental group (Flange FITS Guide sizing method) or the control group (flange manufacturers sizing guide).
The investigators hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
Aims:
- Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.
- Determine in there is an increase in comfort with breastfeeding, breastfeeding satisfaction, length of pumping with the use of the Flange FITS TM Guide sizing method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention is the type of fitting provided for using the pump. Usual fitting versus the FLANGEFITs protocol.
| Arm | Type | Receives |
|---|---|---|
| Control/usual care | Active comparator | Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.Pumping people will be provided the usual education and flange fitting procedures. |
| Intervention group | Experimental | Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.This groups will receive the FLANGEFITS protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have newborn in NICU
- Using a breast pump Ability to pump 6-8 times a day
Key exclusion criteria (1 listed)
- Not using a breast pump No newborn in the NICU
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 |
|---|---|---|
| The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. | Other | Control/usual care, Intervention group |
Primary outcome
Weight of milk
Time frame: Maximum participation is 3 weeks
The weight of the milk will be collected. A food grade scale will be used.
1 secondary outcome
Pumping satisfaction
Time frame: Maximum participation in 3 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 22834882Purdy IB, Singh N, Le C, Bell C, Whiteside C, Collins M. Biophysiologic and social stress relationships with breast milk feeding pre- and post-discharge from the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):347-57. doi: 10.1111/j.1552-6909.2012.01368.x.
- Results publication: PubMed 23867708Alves E, Rodrigues C, Fraga S, Barros H, Silva S. Parents' views on factors that help or hinder breast milk supply in neonatal care units: systematic review. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F511-7. doi: 10.1136/archdischild-2013-304029. Epub 2013 Jul 18.
- Results publication: PubMed 35062895Anders LA, Robinson K, Ohlendorf JM, Hanson L. Unseen, unheard: a qualitative analysis of women's experiences of exclusively expressing breast milk. BMC Pregnancy Childbirth. 2022 Jan 21;22(1):58. doi: 10.1186/s12884-022-04388-6.
- Results publication: PubMed 35921640Meek JY, Noble L; Section on Breastfeeding. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics. 2022 Jul 1;150(1):e2022057988. doi: 10.1542/peds.2022-057988.
- Results publication: PubMed 29427014Lau CYK, Lok KYW, Tarrant M. Breastfeeding Duration and the Theory of Planned Behavior and Breastfeeding Self-Efficacy Framework: A Systematic Review of Observational Studies. Matern Child Health J. 2018 Mar;22(3):327-342. doi: 10.1007/s10995-018-2453-x.
- Individual participant dataSharing planned: No. This is a small internal grant. We also need to protect the privacy of participants. We plan to publish results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. in people with Human Milk/Breastfeeding and Breast Pumping, run by University of Maryland, Baltimore 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Weight of milk (time frame: Maximum participation is 3 weeks). 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 NCT07268105, 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 17 Mar 2026.