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

University of Florida

Status: Completed

Conditions: Breast Milk Expression

Treatments: Behavioral: Early initiation; Behavioral: Late initiation; Behavioral: Intermediate expression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01892085

1R15NR013566-01A1 (U.S. NIH Grant/Contract)

2012-00071-N

IRB201200071 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Early initiation

Experimental group

Description:

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

Treatment:

Behavioral: Early initiation

Intermediate expression

Experimental group

Description:

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

Treatment:

Behavioral: Intermediate expression

Late initiation

Other group

Description:

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

Treatment:

Behavioral: Late initiation