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Completed

NCT Number: NCT01892085

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

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Key information

Conditions

Breast Milk Expression Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Shands

Gainesville, Florida, 32605, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early initiation

Behavioral

Initiation of breast milk expression <1 hour following delivery.

Other names: Early initiation of breast milk expressed

Intermediate expression

Behavioral

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

Other names: Intermediate timing of breast milk expression

Late initiation

Behavioral

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

Other names: Late initiation of breast milk expression.

Primary outcomes

  1. Pumped Milk Volume Day 1

    Time frame: Day 1 postpartum

    Volume of pumped milk on day 1 postpartum

  2. Pumped Milk Volume on Day 2

    Time frame: Day 2 postpartum

    Volume of breast milk pumped on day 2 postpartum

  3. Pumped Milk Volume Day 3

    Time frame: Day 3 postpartum

    Volume of milk pumped on day 3 postpartum

  4. Pumped Milk Volume Day 4

    Time frame: Day 4 postpartum

    Volume of pumped milk on Day 4 postpartum

  5. Pumped Milk Volume on Day 5

    Time frame: Day 5 postpartum

    Volume of pumped milk on Day 5 postpartum

  6. Pumped Milk Volume Day 6

    Time frame: Day 6 postpartum

    Volume of pumped milk on Day 6 postpartum

  7. Pumped Milk Volume on Day 7

    Time frame: Day 7 postpartum

    Volume of milk pumped on day 7 postpartum

  8. Pumped Milk Volume at Day 14

    Time frame: Day 14 postpartum

    Volume of pumped milk on day 14 postpartum

  9. Pumped Milk Volume Day 21

    Time frame: Day 21 postpartum

    Volume of milk pumped on day 21 postpartum

  10. Pumped Milk Volume Day 28

    Time frame: Day 28 postpartum

    Volume of milk pumped on day 28 postpartum

  11. Pumped Milk Volume on Day 35

    Time frame: Day 35 postpartum

    Volume of milk pumped on day 35 postpartum

  12. Pumped Milk Volume on Day 42

    Time frame: Day 42 postpartum

    Volume of milk pumped on day 42 postpartum

Secondary outcomes

  1. 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

  2. Days Lactated

    Time frame: birth to approximately 3 months

    Days mothers lactated until infant NICU discharge

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 3, 2013
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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