Bedtime Routine for Newborns

Overseen By Robert Vera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Disqualifiers: Allergies, Health condition, Skin condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bedtime Routine for Newborns?

Research shows that establishing bedtime routines in the first year of life can lead to better sleep outcomes, such as longer sleep duration and fewer nighttime awakenings, across the first two years of life. Additionally, specific bedtime activities like reading a book are linked to improved sleep. ^{1 2 3 4 5}

Is a bedtime routine for newborns safe?

Research shows that following safe sleep practices, like placing babies on their backs to sleep and using a firm sleep surface, can reduce the risk of sleep-related infant deaths. These practices are recommended by the American Academy of Pediatrics to ensure a safe sleep environment for newborns. ^{6 7 8 9 10}

How does the Bedtime Routine treatment for newborns differ from other treatments?

The Bedtime Routine treatment is unique because it focuses on establishing consistent bedtime activities, like reading and bathing, to improve sleep and development in newborns, and it uses a novel approach by providing support through automated text messages for first-time parents. Unlike other treatments, it emphasizes non-pharmacological methods and the importance of a set bedtime to enhance sleep quality. ^{2 4 11 12 13}

What is the purpose of this trial?

The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.

Research Team

Nancy Rodgers, Ph.D.

Principal Investigator

SGS North America, Inc.

Eligibility Criteria

This clinical trial is for newborns. Specific eligibility criteria are not detailed, but typically participants would be healthy infants with caregivers willing to follow the study's routine and complete questionnaires.

Inclusion Criteria

Infant must be breastfed, formula-fed, or combination

Infant must be full term at birth (gestational age >= 37 weeks)

Infant must be a singleton birth (only 1 child per household may be enrolled)

Exclusion Criteria

Caregiver and infant must not have known allergies or adverse reactions to common topical skincare products or the ingredients in the investigational study materials

Caregiver and infant must not have a history of or a concurrent health condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study

Caregiver and infant must not be simultaneously participating in any other clinical study or have participated in a clinical study since infant's birth

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants in the intervention group are provided with instructions for a daily bedtime routine for their infant, including a massage with a moisturizing lotion

1 week

Intervention

Participants in the intervention group use the provided wash/shampoo and lotion for their baby, following the bedtime routine

6 months

Follow-up

Participants are monitored for the acceptability and feasibility of the bedtime routine via caregiver questionnaire

4 weeks

Treatment Details

Interventions

• Bedtime Routine

Trial Overview The trial is testing a bedtime routine that includes using body lotion, daily activities, and baby wash/shampoo on neonates. Caregivers will report their experiences through a questionnaire.

Participant Groups

Group I: Interventional Group (Wash/Shampoo and Lotion) Experimental Treatment 2 Interventions

Participants in the intervention group will use the provided wash/shampoo, and face and body lotion for their baby. At Baseline, participants caregivers in the intervention group will be provided with instructions for institution of a daily bedtime routine for their infant, which includes a massage with a moisturizing lotion.

Group II: Control Group Active Control 1 Intervention

Participants in the control group will follow their typical daily activities with their baby throughout the study, including their typical bathing, skincare, and sleep practices.

Who Is Running the Clinical Trial?

Johnson & Johnson Consumer Inc. (J&JCI)

Lead Sponsor

Trials

57

Recruited

5,700+

Findings from Research

A systematic review of 27 studies on Quality Improvement (QI) processes in hospitals showed that various strategies, including staff and parent education, effectively increased adherence to safe infant sleep recommendations.

All reviewed articles reported at least partial success in improving practices like placing infants in a supine position and ensuring cribs are free of objects, highlighting the importance of tailored QI efforts in different hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based inpatient quality improvement initiatives on safe infant sleep: Systematic review and narrative synthesis. Salm Ward, TC., Yasin, T.[2022]

The study aims to develop an evidence-based bedtime routine intervention for first-time parents using text messages, addressing the importance of bedtime routines for children's health and development.

A small-scale feasibility study with 50 participants will assess the intervention's effectiveness and engagement, potentially leading to a larger, more comprehensive study if it meets the APEASE criteria for acceptability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedtime Routines Intervention for Children (BRIC) using an automated text messaging system for behaviour change: study protocol for an early phase study. Kitsaras, G., Allan, J., Pretty, IA.[2022]

A deep learning algorithm developed for monitoring sleep states in neonates achieved high accuracy, detecting quiet sleep with 90% accuracy in training data and 81% in an independent polysomnography dataset.

The Sleep State Trend (SST) visualization tool provides an intuitive way for caregivers to monitor sleep state fluctuations in real-time, enhancing bedside care in neonatal intensive care units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep State Trend (SST), a bedside measure of neonatal sleep state fluctuations based on single EEG channels. Montazeri, S., Nevalainen, P., Stevenson, NJ., et al.[2022]

Establishing consistent bedtime routines in the first year of life is linked to better sleep outcomes, such as less nighttime waking and fewer sleep problems, as observed in a study of 468 children over their first two years.

Engaging in adaptive bedtime activities, like reading books, is associated with longer sleep duration and fewer sleep issues, suggesting that both routine consistency and specific activities play important roles in improving children's sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedtimes, bedtime routines, and children's sleep across the first 2 years of life. Fiese, BH., Cai, T., Sutter, C., et al.[2021]

The REST routine, a home-based nursing intervention for infants with excessive irritability or colic, significantly reduced crying time from an average of 3 hours per day in the control group to 1.3 hours per day in the treatment group, indicating its efficacy (p = .02).

At the 8-week follow-up, 62% of infants in the REST routine group had their irritability resolved (crying less than 1 hour), compared to only 29% in the control group, highlighting the program's effectiveness in improving infant well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention program for families with irritable infants. Keefe, MR., Barbosa, GA., Froese-Fretz, A., et al.[2019]

The Safe Start Study is a randomized controlled trial designed to evaluate the effectiveness of a safe sleep education intervention for parents during well child visits, involving mother-baby dyads from a large urban pediatric practice.

The study aims to improve infant sleep safety by measuring changes in parents' knowledge and behaviors regarding safe sleep practices, with primary outcomes including self-reported behaviors and observations of the sleep environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. McDonald, EM., Davani, A., Price, A., et al.[2021]

A quality improvement initiative in a level IV NICU significantly increased the percentage of eligible infants placed in safe sleep environments from 13% to 81% after implementing an evidence-based safe sleep bundle, based on audits of 744 infants over 5 months.

The initiative demonstrated that modeling and endorsing safe sleep practices in the NICU can lead to substantial improvements in compliance, which may positively influence caregivers' practices at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Safe Sleep Practices in the Neonatal Intensive Care Unit. Paul, ET.[2023]

Approximately 3500 infants die each year in the U.S. from sleep-related causes, including SIDS, highlighting the urgent need for effective prevention strategies.

The American Academy of Pediatrics recommends a safe sleep environment, including placing infants on their backs to sleep, using a firm mattress, and avoiding soft bedding, which can significantly reduce the risk of sleep-related infant deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SIDS and Other Sleep-Related Infant Deaths: Evidence Base for 2016 Updated Recommendations for a Safe Infant Sleeping Environment. Moon, RY.[2022]

A project in a neonatal intensive care unit (NICU) revised its safe sleep policy based on updated American Academy of Pediatrics (AAP) recommendations, leading to a significant increase in safe sleep compliance from 21% to 88% among eligible infants.

The implementation of staff education, family resources, and wearable blankets contributed to improved patient safety by promoting safer sleep environments for infants, effectively reducing the risk of Sudden Infant Death Syndrome (SIDS) and accidental suffocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing safe sleep practices in a neonatal intensive care unit. Voos, KC., Terreros, A., Larimore, P., et al.[2022]

Implementing safe sleep practices can significantly lower the risk of sleep-related deaths in infants, highlighting the importance of proper sleeping environments.

Educating caregivers about safe sleep guidelines is crucial for enhancing infant safety during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Practices in the United States. Bombard, JM., Kortsmit, K., Cottengim, C., et al.[2021]

In a study involving 20 preterm infants, there were no significant differences in heart rate and oxygen saturation between nesting and hammock positions after diaper changes.

However, the hammock position was associated with improved sleep patterns in preterm infants, indicating that while both positions are similar physiologically, the hammock may enhance sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hammock and nesting in preterm infants: randomized controlled trial. Costa, KSF., Fernandes, DDS., Paula, RAP., et al.[2020]

Infants who had earlier sleep onset experienced significantly longer total nighttime sleep, with an increase of about 34.4 minutes for every hour earlier they fell asleep, based on a study of 24 infants monitored over three weeks.

A consistent bedtime routine and avoiding feeding infants to sleep were associated with longer nighttime sleep at 6 weeks of age, suggesting that establishing good sleep habits early on can promote better sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy. Adams, EL., Savage, JS., Master, L., et al.[2021]

In a randomized clinical trial involving 76 preterm neonates in a NICU, the nesting method (using rolled cotton sheets) significantly increased sleep duration compared to the swaddling method, with averages of 206.4 minutes versus 183.1 minutes.

Nesting also resulted in fewer instances of waking up during sleep, suggesting it is a beneficial non-pharmacological approach to improve sleep quality in preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effect of Nesting and Swaddling on Sleep Duration and Arousal Frequency among Preterm Neonates: A Randomized Clinical Trial. Vadakkan, AJ., Prabakaran, V.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Hospital-based inpatient quality improvement initiatives on safe infant sleep: Systematic review and narrative synthesis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Bedtime Routines Intervention for Children (BRIC) using an automated text messaging system for behaviour change: study protocol for an early phase study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep State Trend (SST), a bedside measure of neonatal sleep state fluctuations based on single EEG channels. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bedtimes, bedtime routines, and children's sleep across the first 2 years of life. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An intervention program for families with irritable infants. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Increasing Safe Sleep Practices in the Neonatal Intensive Care Unit. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

SIDS and Other Sleep-Related Infant Deaths: Evidence Base for 2016 Updated Recommendations for a Safe Infant Sleeping Environment. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Implementing safe sleep practices in a neonatal intensive care unit. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Practices in the United States. [2021]

11. Brazil pubmed.ncbi.nlm.nih.gov

Hammock and nesting in preterm infants: randomized controlled trial. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy. [2021]

13. Iran pubmed.ncbi.nlm.nih.gov

Comparison of the Effect of Nesting and Swaddling on Sleep Duration and Arousal Frequency among Preterm Neonates: A Randomized Clinical Trial. [2022]