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NCT Number: NCT06673160

Pumping to Up Maternal Milk Production for Preterms

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.

Recruiting

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pumping every 2 hours

Behavioral

The intervention will be pumping every 2 hours.

Other names: breast pumping every 2 hours

breast pumping every 3 hours

Behavioral

The intervention will be pumping every 3 hours

Primary outcomes

  1. 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

Secondary outcomes

  1. The percentage of donor breast milk feedings

    Time frame: From enrollment to 28 days of life

    This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk.

  2. The number of days alive on full feedings

    Time frame: From enrollment to 28 days of life

    The total number of days the infant received full enteral feeds (≥120 milliliters(mL)/kilogram(kg)/day).

  3. The time to full feedings

    Time frame: From enrollment to 28 days of life

    The number of days it takes to initially reach full enteral feeds (≥120mL/kg/day)

  4. The number of infants with clinical evidence of feeding intolerance

    Time frame: From enrollment to first 28 days after birth

    Infants that have enteral feeds withheld, or in other words made "nothing by mouth" (NPO) > 24 hours for feeding or abdominal issues

  5. Number of central line days

    Time frame: In the first 28 days of life

    The total number of days the infant maintained any type of central line access.

  6. The number of infants receiving any volume of breastmilk at time of discharge

    Time frame: From enrollment to hospital discharge

    Infants who are still receiving any volume of expressed breastmilk upon discharge will be identified and noted.

  7. The number of infants exclusively feeding breastmilk at discharge

    Time frame: From enrollment to hospital discharge

    Whether or not enrolled infants are receiving all their nutrition from their mom's own expressed breastmilk upon discharge will be noted

  8. Average change in weight

    Time frame: from birth to 36 weeks' corrected gestational age

    Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age

  9. Average change in length

    Time frame: from birth to 36 weeks corrected gestational age

    Changes in length measured in centimeters (cm)

  10. Average change in head circumference

    Time frame: from birth to 36 weeks' corrected gestational age

    Change in head circumference measured in centimeters (cm)

  11. The Bayley Scales of Infant and Toddler Development (BSID)

    Time frame: from 18-26 months of age

    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.

  12. The Bayley Scales of Infant and Toddler Development (BSID)

    Time frame: From 18-26 months of age

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Colm Travers, MD

CONTACT

[email protected]

205-934-8793

Folasade Aderibigbe, MD

CONTACT

[email protected]

205-934-8793

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Pumping to Up Maternal Milk Production for Preterms (PUMMPP)

Acronym: PUMMPP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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