Morbidity and mortality among very-low-birth-weight neonates with intrauterine growth restriction

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)61577-8.pdf

Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review.

Despite the consensus that national cesarean-section rates are excessive, they continue to rise. Currently, approximately one of every four deliveries is by cesarean section. We developed an initiative to reduce the number of cesarean deliveries to a rate of 11 percent of all deliveries at our inner-city hospital. Participation by attending physicians was voluntary and not linked to any sanction. The program included a stringent requirement for a second opinion, objective criteria for the four most common indications for cesarean section, and a detailed review of all cesarean sections and of individual physicians' rates of performing them. During the first two years of the program, the cesarean-section rate fell from 17.5 percent of 1697 deliveries in 1985 to 11.5 percent of 2301 deliveries in 1987 (P less than 0.05). The proportion of infants with five-minute Apgar scores lower than 7 increased from 3 percent in 1985 to 4.9 percent in 1987 (P less than 0.05), but neither the fetal mortality rate (11.9 per 1000) nor the neonatal mortality rate (11.2 per 1000) in 1987 differed significantly from the rates in 1985. A single maternal death, unrelated to cesarean delivery, occurred during the study. Rates of both primary and repeat cesarean sections decreased, although only the decline in the rate of primary cesarean sections, from 12 to 6.8 percent, was statistically significant (P less than 0.05). During the same period, operative vaginal deliveries (i.e., forceps deliveries and midpelvic procedures) declined from 10.4 to 4.3 percent (P less than 0.05) of total deliveries. We conclude that an initiative within an obstetrics department can reduce cesarean-section rates substantially without adverse effects on the outcome for mother or infant.

A successful program to lower cesarean-section rates.

Infants with birth weights under 750 g are disproportionately represented in perinatal mortality and morbidity rates. We reviewed the outcomes of 98 infants delivered at our perinatal center between July 1982 and June 1985 (period 1) whose lengths of gestation were 20 or more weeks and whose birth weights were under 750 g, and compared them with the outcomes of 129 such infants born between July 1985 and June 1988 (period 2). The frequency of cesarean section increased from 12 to 19 percent between the two periods. During the entire six-year period, 12 percent of the infants with birth weights under 500 g were intubated, as compared with 28 percent of those between 500 and 599 g, 60 percent of those between 600 and 699 g, and 90 percent of those between 700 and 749 g. The frequency of endotracheal intubation increased between the two periods only for infants with birth weights above 500 g (P less than 0.02). Despite more aggressive treatment, survival did not change, although the mean time to death among infants transferred to the neonatal intensive care unit increased from 73 to 880 hours. Among all live-born infants with birth weights under 750 g, the rate of survival was 20 percent during period 1 and 18 percent during period 2, but 48 and 43 percent of those transferred to the neonatal intensive care unit survived in the two periods reviewed. Neonatal morbidity also did not change. Among survivors at a corrected age of 20 months, 4 of 18 born during period 1 and 7 of 14 born during period 2 had moderate-to-severe neurodevelopmental impairment. When all live-born infants of less than 28 weeks' gestation were considered, only 8 percent of those born at 23 weeks survived, as compared with 16 percent of those born at 24 weeks, and 53, 63, and 72 percent of those born at 25, 26, 27 weeks, respectively. Thus, despite a tendency to perform more cesarean sections and active resuscitations, no improvement in the survival of babies with lengths of gestation below 25 weeks or birth weights under 750 g was observed. The probability of survival is very poor if the length of gestation is less than 24 weeks or the birth weight less than 600 g.

Outcomes of Extremely-Low-Birth-Weight Infants between 1982 and 1988

Objective: To investigate the changing prognosis for babies of less than 28 weeks9 gestation. Design: A prospective, collaborative, population based survey. Setting: The former Northern Regional Health Authority. Subjects: All the births between 1983 and 1994 at 22 to 27 completed weeks9 gestation to women normally resident in the region. Main outcome measures: Miscarriage, stillbirth, death in the first year of life, and disability in survivors. Results: There were 479 070 registered births in the study period. No baby of 22 weeks9 gestation survived; only eight (4%) of the 197 babies of 23 weeks who were alive at the onset of labour survived for a year–a proportion that did not change during the study period. Survival among other babies of less than 28 weeks improved progressively between 1983-6 and 1991-4, but administration of artificial surfactant to babies requiring ventilation from mid-1990 was associated with further improvement in survival only in those over 25 weeks9 gestation. Babies of 24 weeks required three times as much high dependency care per survivor as babies of 27 weeks (76 v 26 days). The rate of severe disability in the one year survivors of less than 26 weeks9 gestation (30/123; 24%) was similar to that seen in the sampled survivors of 26 and 27 weeks (29/108; 27%); the proportion disabled did not change significantly during the study period. All the children born in 1983, 1987, and 1991 were later reassessed in greater detail: 10% (13/136) seemed destined for a continuing life of total dependency. Conclusions: Gestation, if accurately assessed, can give a woman facing very preterm delivery a clear indication of the prognosis for her baby and help her judge the appropriateness of accepting obstetric intervention and sustained perinatal support. Key messages Survival in babies of 24-27 completed weeks of gestation has improved in the past 12 years The proportion of survivors with severe disability (25%) has not changed The survival (viability) of babies born before 24 weeks9 gestation (about 4%) has not changed, and most survivors are severely disabled One in 10 of all survivors has a disability so profound that he or she is never likely to become independently mobile or to communicate effectively with others Gestation, if accurately assessed, can help women facing very preterm delivery (and their attendants) to assess the likely prognosis for the baby at the onset of labour

/pdf/changing-prognosis-for-babies-of-less-than-28-weeks-2nznkt4ft2.pdf

Changing prognosis for babies of less than 28 weeks' gestation in the north of England between 1983 and 1994. Northern Neonatal Network.

Cesarean section or vaginal delivery at 24 to 28 weeks' gestation: comparison of survival and neonatal and two-year morbidity.

BACKGROUND
Cardiosphere-derived cells (CDCs) ameliorate skeletal and cardiac muscle deterioration in experimental models of Duchenne muscular dystrophy. The HOPE-2 trial examined the safety and efficacy of sequential intravenous infusions of human allogeneic CDCs in late-stage Duchenne muscular dystrophy.


METHODS
In this multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, patients with Duchenne muscular dystrophy, aged 10 years or older with moderate upper limb impairment, were enrolled at seven centres in the USA. Patients were randomly assigned (1:1) using stratified permuted blocks to receive CAP-1002 (1·5 × 108 CDCs) or placebo intravenously every 3 months for a total of four infusions. Clinicians, caregivers, patients, and clinical operations personnel were fully masked to treatment groups. The primary outcome was the change in mid-level elbow Performance of Upper Limb version 1.2 (PUL 1.2) score at 12 months, assessed in the intention-to-treat population. Safety was assessed in all individuals who received an investigational product. This trial is registered with ClinicalTrials.gov, NCT03406780.


FINDINGS
Between March 1, 2018, and March 31, 2020, 26 male patients with Duchenne muscular dystrophy were enrolled, of whom eight were randomly assigned to the CAP-1002 group and 12 to the placebo group (six were not randomised due to screening failure). In patients who had a post-treatment PUL 1.2 assessment (eight in the CAP-1002 group and 11 in the placebo group), the mean 12-month change from baseline in mid-level elbow PUL1.2 favoured CAP-1002 over placebo (percentile difference 36·2, 95% CI 12·7-59·7; difference of 2·6 points; p=0·014). Infusion-related hypersensitivity reactions without long-term sequelae were observed in three patients, with one patient discontinuing therapy due to a severe allergic reaction. No other major adverse reactions were noted, and no deaths occurred.


INTERPRETATION
CAP-1002 cell therapy appears to be safe and effective in reducing deterioration of upper limb function in patients with late-stage Duchenne muscular dystrophy. Various measures of cardiac function and structure were also improved in the CAP-1002 group compared with the placebo group. Longer-term extension studies are needed to confirm the therapeutic durability and safety of CAP-1002 beyond 12 months for the treatment of skeletal myopathy and cardiomyopathy in Duchenne muscular dystrophy.


FUNDING
Capricor Therapeutics.

Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

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Cesarean section or vaginal delivery at 24 to 28 weeks' gestation: comparison of survival and neonatal and two-year morbidity.

Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial