Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates - A Pilot Study
Phase: NA
Conditions: Safety Issues
Sponsor: University Hospitals Cleveland Medical Center

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Cover Page 
 
 
Official Study Title: Safety of Immediate Skin-To-Skin Contact after Vaginal Birth in Vigorous Late-
Preterm Neonates – A Pilot Study 
 
 
NCT Number: 03585192 
 
 
Protocol Date: October 24, 2017 
 
 
Date of Document: August 21, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol 
I. Inclusion Criteria 
1. Singletons born 35 0/7 to 36 6/7 weeks GA via vaginal delivery  
2. Vigorous - crying, good respiratory effort, good tone  
3. No major congenital malformation 
 
II. Recruitment 
1. Recruitment will occur at UH MacDonald Women’s Hospital.  
2. Mothers who meet the inclusion criteria will be tracked in the EMR at time of admission to the 
Labor & Delivery Unit.  
3. Informed consent will be obtained by members of the research team. 
a. Consenting process will occur at the time of Mother’s admission to the Labor & 
Delivery Unit.  
b. Consent will be obtained in Mother’s room.  
c. Mother will not be consented if sedated, under distress from laboring process, or 
clinically unstable per Labor & Delivery Team. 
 
III. Randomization 
1. Index cards with skin or warmer written on them will be placed in opaque, sealed envelopes.  
2. The envelopes will be shuffled randomly and numbered 1-120. The envelopes will be kept in 
chronological order. Extra envelopes containing index cards will be made if needed using the same 
randomized process. The investigators anticipate needing approximately 30% more randomized 
envelopes than what has been calculated by our Statistician due to unplanned deliveries in which 
the Mother was planning to have a vaginal birth and needs to undergo a cesarean section, either 
the Mother or neonate are unstable after delivery, or Mother's decision to withdrawal from the 
study. In the event of the above scenarios, an additional Mother-neonate dyad will need to be 
randomized in order to achieve our goal of 92 neonates for study completion.  
3. Envelopes will be stored in the Neonatal Treatment Room adjacent to Operation Room 1 on the 
Labor & Delivery Unit.  
4. After obtaining informed consent and if the Mother is agreeable to participate in this study, a sealed 
envelope will be brought to laboring room and opened prior to delivery. No one in the delivery room 
will know what is written on the index card. The envelope will be opened right before delivery.  
5. Skin is the intervention group (Group 1) and warmer is the control group (Group 2)  
6. Skin (Group 1) 
a. If the newborn is vigorous (crying, good respiratory effort, good tone) after vaginal delivery, 
newborn will be able to go directly to Mother’s chest for immediate SSC  
b. A pulse oximeter will be placed on the newborn’s right wrist. Saturations will be monitored on a 
pulse oximeter located next to the Mother’s bed.  

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7. Warmer (Group 2) 
a. Newborn will go to the radiant warmer, pulse oximeter placed on newborn’s right wrist, and 
saturations will be monitored on the Panda Warmer.  
b. If stable per Baby RN after 20 minutes of observation, the newborn will be placed on Mother’s 
chest for SSC.  
8. In the event that the Mother agrees to the study and is randomized into the control group but 
requests SSC, Mother will be informed that UH standard of care does not allow this practice for 
late-preterm neonates outside of this study and the Mother is free to stop participation in the study 
at any time.  
9. Information about how the newborn transitioned after birth will be collected, regardless if neonate is 
in the skin or warmer group. The information gathered will be analyzed to determine if there are 
any differences in postnatal transitioning between the two groups of newborns. 
 
IV. Study Methods 
Preparation prior to vaginal delivery (all late-preterm neonates) 
1. Prepare Mother to receive newborn (bra removed & uncover breasts)  
2. Place warm blanket on Mother’s abdomen to receive neonate.  
3. Pulse oximeter will be turned on and placed bedside to allow uninterrupted contact and positioning 
between Mother and neonate. Screen is to be visible to Labor & Delivery RN at all times. 
 
Initiate immediate SSC after vaginal birth of vigorous late-preterm neonate – Group 1 (skin) 
1. Newborn Nurse will assist Mother with initiating skin-to-skin contact  
2. Place nude neonate supine on warm blanket on Mother’s abdomen  
3. Suction mouth and nose if necessary, dry, & remove wet blanket  
4. Place pulse oximeter on right upper extremity, hat, diaper, and cover with warm receiving blanket  
5. Assign 1 minute APGAR  
6. Any change in clinical status of either Mother (based on clinical judgment by OB Physician or 
Midwife) or neonate (based on clinical judgment by Pediatric Team or Neonate’s RN) will preclude 
continued SSC and warrant immediate intervention until stabilized. 
a. Interventions to stabilize neonate: repositioning on Mother’s chest, ensure unobstructed airway, 
oral suctioning with bulb syringe if needed, reapply pulse oximeter, & remove from Mother’s chest if 
needed. 
Monitoring during postnatal transitioning  
Following standard of care, there is a dedicated baby RN that will be continuously assessing the 
baby in a location consistent with current UH Clinical Practice Guidelines. Routinely, any baby 
doing SSC is not placed on continuous pulse oximetry. However, for the purposes of this study, we 
will place all babies (control and experimental groups) on continuous pulse oximetry to ensure 
safety with SSC. The pulse oximeter will record continuous oxygen saturation and heart rate. 

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1. Following current standard of care, after drying and stimulating with warm blanket, remove the wet 
blanket, and place neonate in prone position on Mother’s bare chest between breasts in upright 
position within 5 minutes of birth  
2. Monitor neonate’s head position and ensure nose is unobstructed  
3. Cover with 2-4 layers of warm receiving blankets  
4. Assign 5 minute APGAR  
5. Neonate to stay on Mother’s chest for uninterrupted SSC for at minimum first 60 minutes of life 
irrespective of timing of first feed. The goal is continuous, monitored SSC within the first 60 minutes 
of life.  
6. Routine vital signs, including pulse oximetry, will be monitored and documented in the EMR until 
Mother/neonate stable for transfer to antepartum unit. Vital signs will be obtained per current UH 
protocol (see attachment – Clinical Practice Guideline Care of the Well Neonate). Normal values 
and assessment data include: 
a. Axillary temperature 36.5-37.5 degrees Celsius  
b. Heart rate of 100 to 180 beats per minute (if not eating or crying)  
c. Regular cardiac rhythm  
d. Respiratory rate of 40-60 breaths per minute  
e. Pulse oximetry parameters per NRP guidelines (see attachment – Foundations of Neonatal 
Resuscitation).  
f. Any pulse oximetry reading < 85% after 10 minutes of life will require the baby to be repositioned 
on Mother’s chest, ensure unobstructed airway, oral suctioning with bulb syringe if needed, reapply 
pulse oximeter, & remove from Mother’s chest if needed.  
g. Any pulse oximetry reading < 88% at 1 hour of life will require the baby to be repositioned on 
Mother’s chest, ensure unobstructed airway, oral suctioning with bulb syringe if needed, reapply 
pulse oximeter, & remove from Mother’s chest if needed.  
h. Screening and management of postnatal glucose homeostasis will be instituted, as is the current 
policy at UH MacHouse Women’s Hospital, for all late-preterm neonates until 24 hours of life (see 
attachment – University Hospitals MacDonald Women’s Hospital Screening and Management of 
Postnatal Glucose Homeostasis).  
7. Signs of tolerance of postnatal SSC: 
1. Pink or with mild acrocyanosis  
2. Respiratory effort easy, no audible grunting, or visible intercostal retractions  
3. Alert, demonstrating feeding cues, or sleeping comfortably  
4. Well-flexed posture with good tone 
8. Any change in clinical status of either Mother (based on clinical judgment by OB Physician or 
Midwife) or neonate (based on clinical judgment by Pediatric Team or Neonate’s RN) will preclude 
continued SSC and warrant immediate intervention until stabilized. 
1. Interventions to stabilize neonate: repositioning on Mother’s chest, ensure unobstructed 
airway, oral suctioning with bulb syringe if needed, reapply pulse oximeter, & remove from 
Mother’s chest if needed. 
 

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Monitoring of late-preterm neonate if randomized to Group 2 (warmer) 
1. Initial period of observation (20 minutes) under the radiant warmer per current UH protocol  
2. Place pulse oximeter on right upper extremity  
3. SSC protocol to be followed as detailed in (numbers 2-8)  
4. Any change in clinical status of either Mother (based on clinical judgment by OB Physician or 
Midwife) or neonate (based on clinical judgment by Pediatric Team or Neonate’s RN) will preclude 
continued SSC and warrant immediate intervention until stabilized. 
a. Interventions to stabilize neonate: repositioning on Mother’s chest, ensure unobstructed airway, 
oral suctioning with bulb syringe if needed, reapply pulse oximeter, & remove from Mother’s chest if 
needed.