Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction

NCT07268105 | Withdrawn

• 1 other identifier: HP-00114021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Pumping; Human Milk/Breastfeeding

Keywords

breast pump; human milk

Outcome Measures

Primary Outcomes (1)

• Weight of milk

  The weight of the milk will be collected. A food grade scale will be used.

  Maximum participation is 3 weeks

Secondary Outcomes (1)

• Pumping satisfaction

  Maximum participation in 3 weeks.

Study Arms (2)

Control/usual care

ACTIVE COMPARATOR

Pumping people will be provided the usual education and flange fitting procedures.

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.

Other: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.

Interventions

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.

Control/usual care; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have newborn in NICU
• Using a breast pump Ability to pump 6-8 times a day

You may not qualify if:

• Not using a breast pump No newborn in the NICU

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (5)

• 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.

  PMID: 22834882 RESULT

• Alves 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.

  PMID: 23867708 RESULT

• Anders 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.

  PMID: 35062895 RESULT

• Meek 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.

  PMID: 35921640 RESULT

• Lau 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.

  PMID: 29427014 RESULT

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is the type of fitting provided for using the pump. Usual fitting versus the FLANGEFITs protocol.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): July 2, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)