Health Trials

Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

ConditionsWell-Being, PsychologicalBreastfeedingLow Birth WeightUndernutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorUniversity of California, San Francisco

About this trial

The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:

* Does listening to a relaxation audiorecording during breastfeeding improve infant growth? * Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety?

Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being.

Participants will:

* Listen to an audiorecording twice daily while breastfeeding for 12 weeks * Have study visits at 1, 2, 4 and 12 weeks for checkups and tests * Let us know what they think of the audiorecording

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newborn low birth weight (LBW) (birth weight < 2500 grams)

Newborn birth weight >= 1800 g

Newborn admitted to Neonatal Intensive Care Unit (NICU)

Newborn in stable condition without WHO danger signs

Disqualifiers

Twins and other multiples

Newborn respiratory support or WHO danger signs

Newborn with major congenital anomaly or expected surgery

Contraindications to or unable to breastfeed

Trial design

Design model

Parallel

Treatments tested in this trial

  • Relaxation audiorecording

    Behavioral

    This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.

  • Control audio device without relaxation audiorecording

    Behavioral

    Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Relaxation AudiorecordingExperimental treatment 1 intervention
Group B: Control audio devicePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in weight-for-age z-score (WAZ)

Weight will be measured with the Seca 334 Infant Scale (Seca Inc., Wandsbek, Germany), which is portable for study visits at home or in hospital or clinic and is accurate to 5 grams. WAZ will be calculated from measured weight using the World Health Organization (WHO) Anthro Survey Analyser. Change in WAZ will be calculated by subtracting WAZ at birth from WAZ at 12 weeks of age.

Time frame
From birth through 12 weeks of age

Secondary outcomes

1

Breastfeeding frequency

Breastfeeding behavior including frequency and duration will be assessed

Time frame
1, 2, 4 and 12 weeks of age
2

Any infant dietary intake other than human milk since last study visit

Infant receipt of any feeding other than human milk since the last study visit will be assessed. We will query mothers about infant dietary intake since the last study visit including human breast milk, formula or any other feeding type such as juice or cow's milk. Infants who have received only human breast milk since the last study visit will be categorized as "no" for this outcome. Infants who have received any type of feeding other than human breast milk will be categorized as "yes" for this outcome.

Time frame
1, 2, 4 and 12 weeks of age
3

Milk transfer

Milk transfer from mother to infant will be measured in grams using the Breast Milk Intake Function of the Seca 334 Infant Scale. We will subtract the infant's pre-feeding weight (measured in grams) from the infant's post-feeding weight (measured in grams) to determine grams of milk transferred from mother to infant during the feeding.

Time frame
1, 2, 4 and 12 weeks of age
4

Maternal stress

Maternal stress will be measured at birth and at 4 and 12 weeks after birth using the Perceived Stress Scale (PSS), a tool which has been validated in the Ugandan postpartum population and which assesses participant stress over the past month. We will use the 10-item version of the PSS which has a minimum score of 0 and a maximum score of 40. Higher scores on the PSS are associated with increased stress.

Time frame
1, 2, 4 and 12 weeks of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Makerere University

Collaborator

Cornell University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: