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

July 31, 2023 updated by: University of Florida

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.

Study Overview

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

  1. Complete a log with information about their daily breast pumping sessions for 6 weeks.
  2. 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.
  3. Episodes of kangaroo care (placing the infant on your bare chest) will be collected.
  4. 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

  1. 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
  2. Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32605
        • University of Florida Shands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early initiation
Initiation of breast milk expression <1 hour following delivery.
Initiation of breast milk expression <1 hour following delivery.
Other Names:
  • Early initiation of breast milk expressed
Experimental: Intermediate expression
Initiation of milk expression 1-<3 hours following delivery.
Initiation of milk expression 1-<3 hours following delivery.
Other Names:
  • Intermediate timing of breast milk expression
Other: Late initiation
Initiation of milk expression >3-6 hours following delivery.
Initiation of milk expression >3-6 hours following delivery.
Other Names:
  • Late initiation of breast milk expression.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours From Birth to Onset of Lactogenesis Stage 2
Time Frame: 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
Hours from birth to onset of lactogenesis stage 2
Days Lactated
Time Frame: birth to approximately 3 months
Days mothers lactated until infant NICU discharge
birth to approximately 3 months
Percentage of Feeds Consisting of Mother's Own Milk Week 1
Time Frame: Day 1 to 7
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Day 1 to 7
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
Time Frame: Day 7-14
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Day 7-14
Percentage of Feeds Consisting of Mother's Own Milk Week 3
Time Frame: Day 14-21
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Day 14-21
Percentage of Feeds Consisting of Mother's Own Milk Week 4
Time Frame: Day 21-28
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Day 21-28
Percentage of Feeds Consisting of Mother's Own Milk Week 5
Time Frame: Day 28-35
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Day 28-35
Percentage of Feeds Consisting of Mother's Own Milk Week 6
Time Frame: Day 35-42
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Day 35-42
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
Time Frame: 24 hour period prior to 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
24 hour period prior to NICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leslie A Parker, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimated)

July 3, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-00071-N
  • 1R15NR013566-01A1 (U.S. NIH Grant/Contract)
  • IRB201200071 (Other Identifier: Univeristy of Florida)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Milk Expression

Clinical Trials on Early initiation

Subscribe