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

Breast Milk Expression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892085
• Other study ID #: 2012-00071-N
• Secondary ID: 1R15NR013566-01A
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 2017

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Breast Milk Expression

Intervention

Behavioral:
• Early initiation
Initiation of breast milk expression <1 hour following delivery.
• Intermediate expression
Initiation of milk expression 1-<3 hours following delivery.
• Late initiation
Initiation of milk expression >3-6 hours following delivery.

Locations

Country	Name	City	State
United States	University of Florida Shands	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pumped Milk Volume Day 1	Volume of pumped milk on day 1 postpartum	Day 1 postpartum
Primary	Pumped Milk Volume on Day 2	Volume of breast milk pumped on day 2 postpartum	Day 2 postpartum
Primary	Pumped Milk Volume Day 3	Volume of milk pumped on day 3 postpartum	Day 3 postpartum
Primary	Pumped Milk Volume Day 4	Volume of pumped milk on Day 4 postpartum	Day 4 postpartum
Primary	Pumped Milk Volume on Day 5	Volume of pumped milk on Day 5 postpartum	Day 5 postpartum
Primary	Pumped Milk Volume Day 6	Volume of pumped milk on Day 6 postpartum	Day 6 postpartum
Primary	Pumped Milk Volume on Day 7	Volume of milk pumped on day 7 postpartum	Day 7 postpartum
Primary	Pumped Milk Volume at Day 14	Volume of pumped milk on day 14 postpartum	Day 14 postpartum
Primary	Pumped Milk Volume Day 21	Volume of milk pumped on day 21 postpartum	Day 21 postpartum
Primary	Pumped Milk Volume Day 28	Volume of milk pumped on day 28 postpartum	Day 28 postpartum
Primary	Pumped Milk Volume on Day 35	Volume of milk pumped on day 35 postpartum	Day 35 postpartum
Primary	Pumped Milk Volume on Day 42	Volume of milk pumped on day 42 postpartum	Day 42 postpartum
Secondary	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
Secondary	Days Lactated	Days mothers lactated until infant NICU discharge	birth to approximately 3 months
Secondary	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	Day 1 to 7
Secondary	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	Day 7-14
Secondary	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	Day 14-21
Secondary	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	Day 21-28
Secondary	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	Day 28-35
Secondary	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	Day 35-42
Secondary	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	24 hour period prior to NICU discharge