An interventional study of Pumping every 2 hours and breast pumping every 3 hours in Breastfeeding and Breastmilk Expression, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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.
88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 49 interventional studies indexed under Breast Milk Expression.
Browse Breast Milk Expression studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Breast Milk Expression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Feeding. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours.
Behavioral: Pumping every 2 hours
Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours.
Behavioral: breast pumping every 3 hours
The intervention will be pumping every 2 hours.
Also known as: breast pumping every 2 hours
The intervention will be pumping every 3 hours
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
Time frame: From enrollment to 28 days of life
The percentage of donor breast milk feedings
This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk.
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to hospital discharge
Average change in weight
Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age
Time frame: from birth to 36 weeks' corrected gestational age
Average change in length
Changes in length measured in centimeters (cm)
Time frame: from birth to 36 weeks corrected gestational age
Average change in head circumference
Change in head circumference measured in centimeters (cm)
Time frame: 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.
Time frame: 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.
Time frame: From 18-26 months of age
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →