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

NCT01892085 | Completed Results

• 3 other identifiers: 2012-00071-N1R15NR013566-01A1IRB201200071
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Milk Expression

Keywords

Breast milk; lactogenesis stage two; premature infant; insufficient milk supply; breast milk expression

Outcome Measures

Primary Outcomes (12)

• Pumped Milk Volume Day 1

  Volume of pumped milk on day 1 postpartum

  Day 1 postpartum

• Pumped Milk Volume on Day 2

  Volume of breast milk pumped on day 2 postpartum

  Day 2 postpartum

• Pumped Milk Volume Day 3

  Volume of milk pumped on day 3 postpartum

  Day 3 postpartum

• Pumped Milk Volume Day 4

  Volume of pumped milk on Day 4 postpartum

  Day 4 postpartum

• Pumped Milk Volume on Day 5

  Volume of pumped milk on Day 5 postpartum

  Day 5 postpartum

• Pumped Milk Volume Day 6

  Volume of pumped milk on Day 6 postpartum

  Day 6 postpartum

• Pumped Milk Volume on Day 7

  Volume of milk pumped on day 7 postpartum

  Day 7 postpartum

• Pumped Milk Volume at Day 14

  Volume of pumped milk on day 14 postpartum

  Day 14 postpartum

• Pumped Milk Volume Day 21

  Volume of milk pumped on day 21 postpartum

  Day 21 postpartum

• Pumped Milk Volume Day 28

  Volume of milk pumped on day 28 postpartum

  Day 28 postpartum

• Pumped Milk Volume on Day 35

  Volume of milk pumped on day 35 postpartum

  Day 35 postpartum

• Pumped Milk Volume on Day 42

  Volume of milk pumped on day 42 postpartum

  Day 42 postpartum

Secondary Outcomes (9)

• Hours From Birth to Onset of Lactogenesis Stage 2

  Hours from birth to onset of lactogenesis stage 2

• Days Lactated

  birth to approximately 3 months

• Percentage of Feeds Consisting of Mother's Own Milk Week 1

  Day 1 to 7

• Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants

  Day 7-14

• Percentage of Feeds Consisting of Mother's Own Milk Week 3

  Day 14-21

Study Arms (3)

Early initiation

EXPERIMENTAL

Initiation of breast milk expression \<1 hour following delivery.

Behavioral: Early initiation

Intermediate expression

EXPERIMENTAL

Initiation of milk expression 1-\<3 hours following delivery.

Behavioral: Intermediate expression

Late initiation

OTHER

Initiation of milk expression \>3-6 hours following delivery.

Behavioral: Late initiation

Interventions

Early initiation BEHAVIORAL

Initiation of breast milk expression \<1 hour following delivery.

Also known as: Early initiation of breast milk expressed

Early initiation

Intermediate expression BEHAVIORAL

Initiation of milk expression 1-\<3 hours following delivery.

Also known as: Intermediate timing of breast milk expression

Intermediate expression

Late initiation BEHAVIORAL

Initiation of milk expression \>3-6 hours following delivery.

Also known as: Late initiation of breast milk expression.

Late initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Florida Shands

Gainesville, Florida, 32605, United States

Location

Related Publications (1)

• 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.

  PMID: 33913765 DERIVED

MeSH Terms

Conditions

Breast Milk Expression; Premature Birth

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Leslie Parker
• Organization: University of Florida

Parkela@ufl.edu

352 215 9360

Study Officials

• Leslie A Parker, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-07

Locations

US (1)