Breast Milk ExpressionNCT01892085

Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants

A study testing Early initiation, Intermediate expression and Late initiation in people with Breast Milk Expression, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Breast Milk Expression
What is being tested?: Early initiation, Intermediate expression and Late initiation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1) at least 18 years of age,
2) English or Spanish-speaking,
3) stated intent to breastfeed,
4) anticipating the birth of a very low birth weight infant (≤1500 grams) between 23-32 weeks gestation.

Who cannot join

1) known illicit maternal drug use,
2) history of breast reduction or augmentation,
3) positive HIV status,
4) mother not transported to recovery by 45 minutes following delivery or
5) infant not expected to live over 2 weeks following delivery.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Shands
Gainesville, Florida, 32605

Other trials in United States

About this study

Official title: Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and decreased breast milk production. Several studies have linked earlier initiation of breast milk expression following delivery with a greater milk production. However, none conclusively determined the optimal timing of breast milk expression. As a result these mothers continue to struggle with inadequate breast milk production. This study will follow 180 mothers of premature infants for 6 weeks following delivery to test

Earlier initiation of breast milk expression following delivery is associated with (1) an earlier lactogenesis stage II, (2) greater volume of breast milk production during the first 6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an earlier gestation will have decreased milk production and a later lactogenesis stage II. Following stratification according to the gestational age of the infant (23-27 weeks vs. 28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6 hours following delivery. The timing of lactogenesis stage II will be documented, and the volume of breast milk produced will continue to be measured for the first 6 weeks following delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week study. The impact of the differences in timing of initiation of milk expression following delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes, amount of breast milk feedings at discharge, and impact of gestational age on milk volume and lactogenesis stage II will be determined.

Read the detailed description

Mothers will be randomly assigned to one of three groups. Group 1 will begin pumping their breasts with the assistance of medical or nursing personnel within 60 minutes following delivery. Group 2 will begin pumping their breasts with the assistance of medical or nursing personnel within 1- less than 3 hours following delivery. Group 3 will begin pumping their breasts with the assistance of medical or nursing personnel 3-6 hours following delivery. Mothers will also do the following

Complete a log with information about their daily breast pumping sessions for 6 weeks.
Bring your breast milk to the neonatal intensive care unit when they visit and the milk will be weighed to determine the volume of milk.
Episodes of kangaroo care (placing the infant on your bare chest) will be collected.
Receive a call beginning the day after you delivery and then daily until their milk comes in to ask about a feeling of fullness in their breasts.

In addition the following will be done

If their infant breastfeeds, he/she will be weighed before and after feeding to collect data on how much milk he/she ate from the breast
Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected

Conditions: Breast Milk Expression
Being tested: Early initiation, Intermediate expression, Late initiation
Keywords: Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression
Medical subject headings: Breast Milk Expression, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early initiationBehavioural
Also called Early initiation of breast milk expressed
Initiation of breast milk expression <1 hour following delivery.
Intermediate expressionBehavioural
Also called Intermediate timing of breast milk expression
Initiation of milk expression 1-<3 hours following delivery.
Late initiationBehavioural
Also called Late initiation of breast milk expression.
Initiation of milk expression >3-6 hours following delivery.

Study groups in NCT01892085
Study group	Role	What they receive
Early initiation	Experimental	Initiation of breast milk expression <1 hour following delivery. Receives: Behavioral: Early initiation
Intermediate expression	Experimental	Initiation of milk expression 1-<3 hours following delivery. Receives: Behavioral: Intermediate expression
Late initiation	Other	Initiation of milk expression >3-6 hours following delivery. Receives: Behavioral: Late initiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Pumped Milk Volume Day 1
Volume of pumped milk on day 1 postpartum
Measured: Day 1 postpartum
Pumped Milk Volume on Day 2
Volume of breast milk pumped on day 2 postpartum
Measured: Day 2 postpartum
Pumped Milk Volume Day 3
Volume of milk pumped on day 3 postpartum
Measured: Day 3 postpartum
Pumped Milk Volume Day 4
Volume of pumped milk on Day 4 postpartum
Measured: Day 4 postpartum
Pumped Milk Volume on Day 5
Volume of pumped milk on Day 5 postpartum
Measured: Day 5 postpartum
Pumped Milk Volume Day 6
Volume of pumped milk on Day 6 postpartum
Measured: Day 6 postpartum
Pumped Milk Volume on Day 7
Volume of milk pumped on day 7 postpartum
Measured: Day 7 postpartum
Pumped Milk Volume at Day 14
Volume of pumped milk on day 14 postpartum
Measured: Day 14 postpartum
Pumped Milk Volume Day 21
Volume of milk pumped on day 21 postpartum
Measured: Day 21 postpartum
Pumped Milk Volume Day 28
Volume of milk pumped on day 28 postpartum
Measured: Day 28 postpartum
Pumped Milk Volume on Day 35
Volume of milk pumped on day 35 postpartum
Measured: Day 35 postpartum
Pumped Milk Volume on Day 42
Volume of milk pumped on day 42 postpartum
Measured: Day 42 postpartum

Secondary outcomes (9)

Hours From Birth to Onset of Lactogenesis Stage 2
Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2
Measured: Hours from birth to onset of lactogenesis stage 2
Days Lactated
Days mothers lactated until infant NICU discharge
Measured: birth to approximately 3 months
Percentage of Feeds Consisting of Mother's Own Milk Week 1
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Measured: Day 1 to 7
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Measured: Day 7-14
Percentage of Feeds Consisting of Mother's Own Milk Week 3
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Measured: Day 14-21
Percentage of Feeds Consisting of Mother's Own Milk Week 4
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Measured: Day 21-28
Percentage of Feeds Consisting of Mother's Own Milk Week 5
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Measured: Day 28-35
Percentage of Feeds Consisting of Mother's Own Milk Week 6
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Measured: Day 35-42
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
The percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate
Measured: 24 hour period prior to NICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Aug 2017

First posted3 Jul 2013 (estimated)
Study startNov 2013
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01892085
Sponsor's protocol ID: 2012-00071-N
Other IDs: 1R15NR013566-01A1, IRB201200071
Status last verified: Jul 2023
First submitted: 28 Jun 2013
Last updated: 24 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Parker LA, Sullivan S, Cacho N, Krueger C, Mueller M. Effect of Postpartum Depo Medroxyprogesterone Acetate on Lactation in Mothers of Very Low-Birth-Weight Infants. Breastfeed Med. 2021 Oct;16(10):835-842. doi: 10.1089/bfm.2020.0336. Epub 2021 Apr 28.
PubMed 33913765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Recruiting
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Breastfeeding, Dietary Intervention
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
Active, not recruitingObservational study
Maternal Obesity, Breast Milk Composition, and Infant Growth
Obesity, Pregnancy
Recruiting
Pumping to Up Maternal Milk Production for Preterms
Breastfeeding, Breastmilk Expression

All Breast Milk Expression trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants
ClinicalTrials.gov ID: NCT01892085
Acronym / sponsor ID: 2012-00071-N
Conditions: Breast Milk Expression
Keywords: Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: Nov 2013
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 3 Jul 2013 (estimated)
Results: Posted 24 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Complete a log with information about their daily breast pumping sessions for 6 weeks.
Bring your breast milk to the neonatal intensive care unit when they visit and the milk will be weighed to determine the volume of milk.
Episodes of kangaroo care (placing the infant on your bare chest) will be collected.
Receive a call beginning the day after you delivery and then daily until their milk comes in to ask about a feeling of fullness in their breasts.

In addition the following will be done

If their infant breastfeeds, he/she will be weighed before and after feeding to collect data on how much milk he/she ate from the breast
Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Early initiation	Experimental	Behavioral: Early initiationInitiation of breast milk expression <1 hour following delivery.
Intermediate expression	Experimental	Behavioral: Intermediate expressionInitiation of milk expression 1-<3 hours following delivery.
Late initiation	Other	Behavioral: Late initiationInitiation of milk expression >3-6 hours following delivery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1) at least 18 years of age,
2) English or Spanish-speaking,
3) stated intent to breastfeed,
4) anticipating the birth of a very low birth weight infant (≤1500 grams) between 23-32 weeks gestation.

Key exclusion criteria (5 listed)

1) known illicit maternal drug use,
2) history of breast reduction or augmentation,
3) positive HIV status,
4) mother not transported to recovery by 45 minutes following delivery or
5) infant not expected to live over 2 weeks following delivery.

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
Early initiationAlso: Early initiation of breast milk expressedInitiation of breast milk expression <1 hour following delivery.	Behavioural	Early initiation
Intermediate expressionAlso: Intermediate timing of breast milk expressionInitiation of milk expression 1-<3 hours following delivery.	Behavioural	Intermediate expression
Late initiationAlso: Late initiation of breast milk expression.Initiation of milk expression >3-6 hours following delivery.	Behavioural	Late initiation

Primary outcome

Pumped Milk Volume Day 1
Time frame: Day 1 postpartum
Volume of pumped milk on day 1 postpartum
Pumped Milk Volume on Day 2
Time frame: Day 2 postpartum
Volume of breast milk pumped on day 2 postpartum
Pumped Milk Volume Day 3
Time frame: Day 3 postpartum
Volume of milk pumped on day 3 postpartum
Pumped Milk Volume Day 4
Time frame: Day 4 postpartum
Volume of pumped milk on Day 4 postpartum
Pumped Milk Volume on Day 5
Time frame: Day 5 postpartum
Volume of pumped milk on Day 5 postpartum
Pumped Milk Volume Day 6
Time frame: Day 6 postpartum
Volume of pumped milk on Day 6 postpartum
Pumped Milk Volume on Day 7
Time frame: Day 7 postpartum
Volume of milk pumped on day 7 postpartum
Pumped Milk Volume at Day 14
Time frame: Day 14 postpartum
Volume of pumped milk on day 14 postpartum
Pumped Milk Volume Day 21
Time frame: Day 21 postpartum
Volume of milk pumped on day 21 postpartum
Pumped Milk Volume Day 28
Time frame: Day 28 postpartum
Volume of milk pumped on day 28 postpartum
Pumped Milk Volume on Day 35
Time frame: Day 35 postpartum
Volume of milk pumped on day 35 postpartum
Pumped Milk Volume on Day 42
Time frame: Day 42 postpartum
Volume of milk pumped on day 42 postpartum

9 secondary outcomes

Hours From Birth to Onset of Lactogenesis Stage 2
Time frame: Hours from birth to onset of lactogenesis stage 2
Days Lactated
Time frame: birth to approximately 3 months
Percentage of Feeds Consisting of Mother's Own Milk Week 1
Time frame: Day 1 to 7
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
Time frame: Day 7-14
Percentage of Feeds Consisting of Mother's Own Milk Week 3
Time frame: Day 14-21
Percentage of Feeds Consisting of Mother's Own Milk Week 4
Time frame: Day 21-28
Percentage of Feeds Consisting of Mother's Own Milk Week 5
Time frame: Day 28-35
Percentage of Feeds Consisting of Mother's Own Milk Week 6
Time frame: Day 35-42
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
Time frame: 24 hour period prior to NICU discharge

Results and safety

Results posted to the registry on 24 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Initiation	58	52
Intermediate Expression	62	61
Late Initiation	60	55

Primary outcome: Pumped Milk Volume Day 1

Time frame: Day 1 postpartum. Least squares mean (Standard Deviation). Unit: mL

Measure	Early Initiation n = 52	Intermediate Expression n = 61	Late Initiation n = 55
Value	3 (3)	4 (4)	5 (4)

Early Initiation vs Late Initiation: p = 0.015, Marginalized two part model
Intermediate Expression vs Late Initiation: p = 0.339, Marginalized two part model

Primary outcome: Pumped Milk Volume on Day 2

Time frame: Day 2 postpartum. Least squares mean (Standard Deviation). Unit: mL

Measure	Early Initiation n = 52	Intermediate Expression n = 61	Late Initiation n = 55
Value	11 (11)	13 (12)	15 (12)

Early Initiation vs Late Initiation: p = 0.024, Marginalized two part model
Intermediate Expression vs Late Initiation: p = 0.317, Marginalized two part model

Primary outcome: Pumped Milk Volume Day 3

Time frame: Day 3 postpartum. Least squares mean (Standard Deviation). Unit: mL

Measure	Early Initiation n = 52	Intermediate Expression n = 61	Late Initiation n = 55
Value	31 (30)	36 (31)	41 (31)

Early Initiation vs Late Initiation: p = 0.031, Marginalized two part model
Intermediate Expression vs Late Initiation: p = 0.298, Marginalized two part model

Primary outcome: Pumped Milk Volume Day 4

Time frame: Day 4 postpartum. Least squares mean (Standard Deviation). Unit: mL

Measure	Early Initiation n = 52	Intermediate Expression n = 61	Late Initiation n = 55
Value	73 (70)	82 (70)	94 (72)

Early Initiation vs Late Initiation: p = 0.05, Marginalized two part model
Intermediate Expression vs Late Initiation: p = 0.27, Marginalized 2 part model

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Initiation	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Intermediate Expression	0 of 61 (0%)	0 of 61 (0%)	0 of 61
Late Initiation	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33913765Parker LA, Sullivan S, Cacho N, Krueger C, Mueller M. Effect of Postpartum Depo Medroxyprogesterone Acetate on Lactation in Mothers of Very Low-Birth-Weight Infants. Breastfeed Med. 2021 Oct;16(10):835-842. doi: 10.1089/bfm.2020.0336. Epub 2021 Apr 28.

Related trials for Breast Milk Expression

Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Recruiting
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Breastfeeding, Dietary Intervention
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
Active, not recruitingObservational study
Maternal Obesity, Breast Milk Composition, and Infant Growth
Obesity, Pregnancy
Recruiting
Pumping to Up Maternal Milk Production for Preterms
Breastfeeding, Breastmilk Expression

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.

Leslie A Parker, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Early initiation, Intermediate expression and Late initiation in people with Breast Milk Expression, run by University of Florida 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Aug 2023. 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?

Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pumped Milk Volume Day 1 (time frame: Day 1 postpartum). The study lists 12 primary outcomes in all. 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 NCT01892085, which also lists 1 linked publication.

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 24 Aug 2023.