Pumping to Up Maternal Milk Production for Preterms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Pumping every 2 hours
BehavioralThe intervention will be pumping every 2 hours.
breast pumping every 3 hours
BehavioralThe intervention will be pumping every 3 hours
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Pumping every 2 hoursExperimental treatment 1 intervention
Group B: Pumping every 3 hoursActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 lifeSecondary outcomes
1
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 life2
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 life3
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 life4
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 birthSponsors and contacts
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Source ClinicalTrials.gov