Neurodevelopmental Intervention for Preterm Infants

Recruiting at 3 trial locations

Overseen By Kate St-Arneault, Ph.D (cand.)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Must not be taking: Analgesics, Sedatives, Paralyzing agents

Disqualifiers: Congenital anomalies, Genetic disorders, others

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

Compensation: Varies

Number of Visits: 1

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to support brain development in preterm infants using a special combination of activities. The research examines the effects of skin-to-skin contact and calming sensory experiences, such as hearing a parent's voice and smelling breast milk, to determine if they aid in the babies' growth. Participants will be divided into two groups: one will receive only skin-to-skin care (SSC alone), while the other will receive additional sensory experiences as part of the NeuroN-QI (Nurturing and Quiet Intervention) program. This trial suits parents of preterm infants born between 24 and 33 weeks who are ready for skin-to-skin contact and can provide breast milk. As an unphased trial, this study offers a unique opportunity for parents to contribute to innovative research that could enhance care for preterm infants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, infants still receiving certain medications like analgesics (pain relievers), sedatives, or paralyzing agents are excluded from the trial.

What prior data suggests that this intervention is safe for preterm infants?

Research has shown that NeuroN-QI, which involves skin-to-skin contact and sound stimulation, is safe for premature babies. Earlier studies examined its practicality and acceptability, finding it well-received. Although detailed safety reports are not highlighted, the emphasis on acceptability suggests no major safety concerns.

For skin-to-skin contact (SSC) alone, studies have demonstrated its safety for premature babies. It does not cause issues like dislodging or breaking medical tubes, indicating it is well-tolerated. SSC is a common practice in newborn care, known to support growth and reduce mortality rates in low birth weight infants.

Both methods emphasize gentle care, which is generally safe and beneficial for babies' development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support the development of preterm infants through sensory stimulation techniques. Unlike traditional care methods such as standard skin-to-skin contact (SSC), the NeuroN-QI treatment adds an extra layer of sensory engagement by incorporating auditory stimulation and controlled environments. This approach includes parents reading to their infants during SSC and using breast milk's scent to promote calm periods, which could enhance neurodevelopmental outcomes. By integrating these elements, the trial aims to discover if these added sensory experiences can provide more significant benefits than the current standard of care.

What evidence suggests that this trial's treatments could be effective for neurodevelopment in preterm infants?

Studies have shown that skin-to-skin contact (SSC), or kangaroo care, has lasting positive effects on preterm infants. It aids brain development and enhances thinking skills. In this trial, one group of participants will receive only SSC, which is crucial for both short- and long-term health outcomes. Another group will receive the NeuroN-QI intervention, which incorporates sounds and smells into SSC. Early findings suggest that these additional sensory experiences, combined with a calm environment, could further support brain development in preterm infants. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 24 and nearly 34 weeks of gestational age, who are stable enough for skin-to-skin contact (SSC). Parents must commit to at least one SSC session per week with auditory stimulation until the infant reaches 36 weeks of gestational age. Mothers should be expressing breast milk for their infants. In case of twins, fathers can also participate.

Inclusion Criteria

ready for SSC

For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.

I was born between 24 and 33 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents and preterm infants engage in skin-to-skin contact and auditory stimulation, followed by a calm period with olfactory stimulation, until the infants reach 36 weeks gestational age.

Until 36 weeks gestational age

At least 1 session weekly, ideally 3

Follow-up

Participants are monitored for neurodevelopmental outcomes and parental stress and anxiety levels.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• NeuroN-QI
• SSC alone

Trial Overview The NeuroN-QI intervention being tested includes parent-infant skin-to-skin contact paired with parental voice sounds and periods of calm without handling but with olfactory stimulation using breast milk. The environment's light and noise levels are controlled to aid neurodevelopment in preterm babies.

How Is the Trial Designed?

Group I: NeuroN-QI Experimental Treatment 1 Intervention

Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.

Group II: SSC alone Active Control 1 Intervention

Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Published Research Related to This Trial

In a study of 80 preterm infants, those placed in lateral decubitus (LD) position showed significantly better improvements in early neuromotor development compared to those in prone position (PP), with the LD group improving in 13 out of 16 assessed items.

The findings suggest that lateral positioning may enhance flexed posture and trunk alignment, which are beneficial for neuromotor development, but further long-term studies are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between positioning of premature infants in Kangaroo Mother Care and early neuromotor development. Barradas, J., Fonseca, A., Guimarães, CL., et al.[2020]

Kangaroo-mother care (KMC) significantly improves neurobehavioral outcomes in preterm infants, as evidenced by higher quality of movements and lower signs of stress compared to those who did not receive KMC.

In a study of 61 preterm infants, those who received KMC for at least 7 days showed better attention and movement quality, indicating that KMC can enhance neurodevelopmental performance between 36 and 41 weeks post-conceptual age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangaroo-mother care method and neurobehavior of preterm infants. Silva, MG., Barros, MC., Pessoa, ÚM., et al.[2016]

Kangaroo Care (K-care) significantly reduces stress-related behaviors in premature infants during painful procedures, such as blood tests, compared to standard crib care.

The positive effects of K-care on reducing motor disorganization and enhancing attention were sustained even after the procedure, suggesting it is beneficial for managing pain in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurobehavioural assessment of skin-to-skin effects on reaction to pain in preterm infants: a randomized, controlled within-subject trial. Ferber, SG., Makhoul, IR.[2008]

Kangaroo care, which involves skin-to-skin contact between preterm infants and their parents, is safe and promotes better attachment between parents and infants, which can enhance nurturing behaviors.

While kangaroo care is associated with positive outcomes for growth and development in preterm infants, the specific impact on weight gain remains uncertain and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of kangaroo care for growth and development in preterm infants. Dodd, VL.[2016]

In a study of 181 very preterm infants, those who received more skin-to-skin (STS) care during hospitalization showed significantly better neurodevelopmental scores at 12 months, suggesting that STS may enhance long-term outcomes.

Specifically, for every additional 20 minutes of STS care per day, infants experienced a notable increase of 10 points in their neurodevelopmental assessments, indicating a strong positive correlation between STS duration and developmental progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient Kangaroo Care Predicts Early Cognitive Development at 6 and 12 Months in Infants Born Very Preterm. Lazarus, MF., Marchman, VA., Brignoni-Pérez, E., et al.[2023]

Kangaroo care (KC) for both 60 and 120 minutes daily significantly improved neurobehavioral performance and breastfeeding success in 120 premature infants compared to conventional care, with better attention and regulation scores.

The 120-minute KC group showed greater improvements in oxygen saturation and temperature, and both KC groups had lower stress levels (measured by salivary cortisol) after 7 days, indicating enhanced overall well-being for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial. El-Farrash, RA., Shinkar, DM., Ragab, DA., et al.[2021]

This systematic review aims to evaluate the effectiveness of interventions like sensory stimulation and parental involvement on the neurodevelopment of preterm infants during their NICU stay, focusing on studies published from 2002 to 2017.

The review will include rigorous methods such as randomized controlled trials and will assess the quality of evidence using the GRADE system, ultimately providing valuable insights for improving neonatal care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions during NICU hospitalization on the neurodevelopment of preterm infants: a systematic review protocol. Aita, M., Stremler, R., Feeley, N., et al.[2022]

In a study of 87 preterm infants, kangaroo holding (skin-to-skin contact) and blanket holding both resulted in better behavioral organization compared to a control group, with infants showing more optimal crying responses.

Both kangaroo and blanket holding provided similar developmental benefits, suggesting that either method can be effective for supporting early development in preterm infants during their first 8 weeks of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of holding practice on preterm infant development. Neu, M., Robinson, J., Schmiege, SJ.[2021]

Kangaroo care (KC) is a highly recommended, natural, and cost-effective intervention for infants, providing numerous benefits such as improved thermoregulation, cardiorespiratory stability, and enhanced breastfeeding outcomes, regardless of the infant's geographic or economic background.

Despite its proven advantages, the adoption of KC in clinical practice is inconsistent, and further research is needed to determine the optimal conditions for its implementation, including the timing, duration, and settings for continuous use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding kangaroo care and its benefits to preterm infants. Campbell-Yeo, ML., Disher, TC., Benoit, BL., et al.[2020]

In a study of 70 preterm infants, those who received Kangaroo Care (skin-to-skin contact) showed a significant improvement in vagal tone maturation between 32 and 37 weeks of gestational age, indicating better autonomic functioning.

Infants who experienced Kangaroo Care also demonstrated enhanced state organization, with longer periods of quiet sleep and alert wakefulness, and a more mature neurodevelopmental profile, particularly in habituation and orientation, compared to those who did not receive this care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin-to-skin contact (Kangaroo Care) accelerates autonomic and neurobehavioural maturation in preterm infants. Feldman, R., Eidelman, AI.[2022]

In a study of 65 preterm infants, those who received kangaroo mother care (KMC) showed significantly improved aEEG activity and neurobehavioral performance compared to those receiving traditional care (TC) on days 7 and 14 after randomization.

KMC infants had higher scores for mature sleep-wake cycling and better neonatal behavioral neurological assessment scores, indicating that KMC may enhance neurological development in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of kangaroo mother care on aEEG activity and neurobehavior in preterm infants: a randomized controlled trial. Wang, Y., Dong, W., Zhang, L., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33719093/

Nurturing and quiet intervention (NeuroN-QI) on preterm ... The NeuroN-QI consists of four 2-hour skin-to-skin contact sessions/week with a 15-minute auditory stimulation by mothers with controlled ambient levels of ...

2. researchgate.net researchgate.net/publication/350064496_Nurturing_and_quiet_intervention_NeuroN-QI_on_preterm_infants'_neurodevelopment_and_maternal_stress_and_anxiety_A_pilot_randomized_clinical_trial_protocol

Nurturing and quiet intervention (NeuroN‐QI) on preterm ... Objectives Primary objective of this pilot study is to evaluate the feasibility and acceptability of the NeuroN‐QI and the study procedures.

3. neocardiolab.com neocardiolab.com/research-recherche/neuron-qi-project

NeuroN-QI project The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers ...

4. withpower.com withpower.com/trial/neurodevelopmental-intervention-for-preterm-infants-864b9

Neurodevelopmental Intervention for Preterm Infants NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11624134/

The effect of early postnatal auditory stimulation on outcomes ... This review explores the range of postnatal auditory stimuli being investigated in the field of neonatology and their effects on preterm infant outcomes.

6. nature.com nature.com/articles/s41390-023-02895-6

Neuroprotective therapies in the NICU in preterm infants The use of antenatal corticosteroids has strong short-term benefits and most likely improves the neurodevelopmental outcomes of preterm neonates ...